The Recall Desk

Archive

August 2012 recalls

875 recalls were announced in August 2012.

What the numbers show

Critical
155
Severe
348
High
251
Moderate
101
Low
20

Of the 875 recalls this month scored against our rubric, 18% are Critical, 40% are Severe.

Which agencies issued them

201–300 of 875

  • SevereFDA (Drugs)·D-1456-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Amphotericin B Drugs Due to Contamination

    Franck's Compounding Lab is recalling sterile Amphotericin B drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML; AMPHOTERICIN B OPHTHALMIC 5MCG/0.1ML INJECTABLE, 0.2 ML, 0.4 ML, 3 ML; AMPHOTERICIN B, LYOPHILIZED 150MCG INJECTABLE 2 VIAL; AMPHOTERICIN-B, NEBULIZATION, STERILE 5MG/2ML N
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1580-2012·2012-08-22

    Franck's Lab Recalls Sterile Midazolam Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile midazolam injectables distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML 300 ML 40 ML 500 ML 90 ML; MIDAZOLAM 5MG/ML INJECTABLE 140 ML 150 ML 200 ML; MIDAZOLAM HCL ***(10X10ML) 5MG/ML INJECTABLE 100 MLS (13 DIFFER
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1483-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs, including Chorionic Gonadotropin, because FDA sampling found microorganisms in the clean room.

    Product
    CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-21 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-45 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1601-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PHENYLEPHRINE/TROPICAMIDE/PROPARACAINE SOLUTION 2.5%/1%/0.5% OPHTHALMIC 120 ML 25 ML 30 ML 5 ML 90 ML (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1531-2012·2012-08-22

    Heparin Sodium Injectable Recall Due to Sterility Assurance Failure

    Franck's Lab Inc. is recalling heparin sodium injectables because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.

    Product
    HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS; HEPARIN SODIUM (25X30ML)** 1000U/ML(1MU/ML) INJECTABLE 120 ML, 60 ML, 90 ML; HEPARIN SODIUM **25X1ML 1000U/ML(1MU/ML INJECTABLE 25 ML, 50 ML (7 DIFFERENT PRODUCT
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1504-2012·2012-08-22

    Franck's Lab Recalls Sterile DMPS Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile DMPS injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1628-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Triamcinolone Acetonide Drugs

    Franck's Compounding Lab is recalling sterile triamcinolone acetonide drugs distributed between November 2011 and May 2012 due to the presence of microorganisms and fungal growth in the clean room.

    Product
    TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE ACETONIDE (T), STSL (0.025ML SYRINGE, 30G, 1/2") 40MG/ML (4MG/0.1M 0.075 SYR 0.1 SYR TRIAMCINOLONE ACETONIDE 0.25ML SYRINGE (T) 40MG/ML (4MG/0.1ML) OPHTHALMIC 0.25 ML 0.5 ML TRIAMC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1528-2012·2012-08-22

    Franck's Lab Recalls Sterile Gentamicin Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile gentamicin products distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER SOLUTION 1000 ML; GENTAMICIN /CLINDAMYCIN /POLYMIXIN B/STERILE WATER 0.1%/0.1%/0.05% SOLUTION 250 ML, 500 ML; GENTAMICIN DROPS (FORTIFIED) 14MG/ML (1.4%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1633-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 ML 576 ML 90 ML (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1644-2012·2012-08-22

    Franck's Lab Recalls Zinc Chloride Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Zinc Chloride 10mg/ml Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.

    Product
    ZINC CHLORIDE 10MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1602-2012·2012-08-22

    Franck's Lab Recalls Pilocarpine Ophthalmic Products Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific Pilocarpine HCL ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    PILOCARPINE HCL P.F IN B.S.S OPHTHALMIC 1% INJECTABLE 36 ML; PILOCARPINE HCL SOLUTION 0.5% OPHTHALMIC 30 ML; PILOCARPINE HCL SOLUTION (PF) 0.5% OPHTHALMIC 30 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1521-2012·2012-08-22

    Franck's Lab Recalls Folic Acid Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Folic Acid 10mg/mL Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.

    Product
    FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1625-2012·2012-08-22

    Recall of Sterile Thiamine HCL Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Thiamine HCL injectable products because FDA sampling found microorganisms and fungal growth in the preparation clean room.

    Product
    THIAMINE HCL 100MG/ML INJECTABLE 300 ML 360 ML 450 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1517-2012·2012-08-22

    Franck's Lab Recalls Etomidate Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Etomidate 0.2% Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.

    Product
    ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1559-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because environmental sampling found microorganisms in the clean room.

    Product
    LIDOCAINE HCL/BUPIVACAINE HCL PF 1%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE HCL/BUPIVACAINE/HYALURONIDASE PF 0.83%/0.312%/16.67U/ML OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE/BUPIVACAINE/HYALURONIDASE PF 1.776%/0.33
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1630-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling specific sterile injectable drugs because FDA sampling found microorganisms and fungal growth in the production clean room.

    Product
    TRIMIX/LIDOCAINE 11.8MG/0.39MG/10.6MCG/1.7MG/ML INJECTABLE 30 ML; TRIMIX/LIDOCAINE 13.6MG/0.45MG/38.2MCG/7.3MG/ML INJECTABLE 10 ML; TRIMIX/LIDOCAINE 12MG/1MG/5MCG/1%/ML INJECTABLE 10 MLS; TRIMIX/LIDOCAINE 17.65MG/0.59MG/5.9MCG/
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1488-2012·2012-08-22

    Franck's Lab Recalls Sterile Cyanocobalamin Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile cyanocobalamin (Vitamin B12) injectables because FDA sampling found microorganisms and fungal growth in the clean room where the products were prepared.

    Product
    CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 300 ML, 32 ML, 4 ML, 5 ML, 6 ML, 60 ML, 90 ML; CYANOCOBALAMIN **1000MCG/ML INJECTABLE 1000MCG/ML INJECTABLE 30 ML; CYANOCOBALAMIN*** (25X10ML V
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1480-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs and ophthalmic products distributed between November 2011 and May 2012 because FDA testing found microorganisms in the production clean room.

    Product
    CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML; CALCIUM EDTA 150MG/ML INJECTABLE 1000 ML, 800 ML, 900 ML; CALCIUM EDTA 300MG/ML INJECTABLE 400 ML, 500 ML; CALCIUM GLUCONATE OPHTHALMIC IN ARTIFICIAL TEARS 1% OPHTHALMIC 500 ML (9 DIFFERENT PRODUC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1530-2012·2012-08-22

    Franck's Lab Recalls Glycerin Ophthalmic Products Due to Sterility Concerns

    Franck's Lab Inc. is recalling four glycerin ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1571-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    METHIONINE / INOSITOL / CHOLINE CHLORIDE 25MG/75MG/75MG/ML INJECTABLE 30 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE 0.8%/1.6%/1.6% INJECTABLE 180 ML 24 ML 240 ML 270 ML 30 ML 90 ML METHIONINE/INOSITOL/CHOLINE CHLORIDE 25MG/50MG/50MG/ML INJECTAB
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1537-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile hyaluronidase/methylprednisolone acetate injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1455-2012·2012-08-22

    Franck's Lab Recalls Aminophylline Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Aminophylline injectable products because FDA testing found microorganisms in the clean room where they were prepared.

    Product
    AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1505-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION 350 ML; DMSO FORTIFIED IRRIGATION 50%/0.01%/44%/1% SOLUTION 1000 ML, 1200 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 600 ML; DMSO FORT
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1481-2012·2012-08-22

    Franck's Lab Recalls Cefazolin Sterile Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile Cefazolin drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIAL (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1447-2012·2012-08-22

    Franck's Lab Recalls Acetazolamide Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Acetazolamide injectable vials because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1475-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Hydromorphone Mixtures

    Franck's Lab Inc. is recalling six sterile intrathecal drug mixtures due to microbial contamination found in the clean room where they were prepared.

    Product
    BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 22MG/30MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/20MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/25MG/ML INTRATHECAL 18 ML; BUPIVACAINE/HYDROMORPH
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1599-2012·2012-08-22

    Franck's Lab Recalls Sterile Phenylephrine Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile phenylephrine injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE 1 ML 10 ML 25 ML 5 ML 50 ML; PHENYLEPHRINE, STSL, P.F. (0.5ML SYRINGE, SLIP-TIP, NO NEEDLE) 1.25% INJECTABLE 5 ML 7.5 ML (8 DIFFER
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1610-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Injectable Drugs Due to Sterility Concerns

    Franck's Compounding Lab is recalling 110 units of QUADMIX injectable drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/1MG/10MCG/100MCG/ML INJECTABLE 1 ML 10 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1573-2012·2012-08-22

    Franck's Lab Recalls Sterile Methylcobalamin Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile methylcobalamin injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30 MLS
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1568-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Sterility Concerns

    Franck's Lab Inc. is recalling 32 units of sterile injectable magnesium products distributed between November 2011 and May 2012 because environmental sampling found microorganisms and fungal growth in the clean room.

    Product
    MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML 750 ML; MAGNESIUM SULFATE 50% (500MG/ML) INJECTABLE 14 ML 20 ML 4 ML; MAGNESIUM SULFATE IN 5% DEXTROSE 1% (1GM/100ML) INJECTABLE 2400 ML;
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1621-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Injectable Drugs Due to Contamination

    Franck's Compounding Lab is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE 50MG/ML INJECTABLE 12 ML 2.5 ML (4 DIFFERENT PRODUCTS) 5 ML; TESTOSTERONE PROPIONATE 200MG/ML INJECTABLE 10 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1577-2012·2012-08-22

    Franck's Lab Recalls Sterile Metoclopramide Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile metoclopramide HCL injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    METOCLOPRAMIDE HCL 5MG/ML (10MG/2ML) INJECTABLE 2 ML 20 ML 200 ML 394 ML 400 ML 498 ML 500 ML 6 ML 600 ML (9 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1541-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Drug Mixtures Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific sterile intrathecal drug mixtures because FDA sampling found microorganisms in the production clean room.

    Product
    HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% SODIUM CHLORIDE) 50MG/500MCG/7.5MG/ML I 18 ML (3 DIFFEENT PROD
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1564-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1469-2012·2012-08-22

    Franck's Lab Recalls Budesonide Nasal Irrigation Due to Sterility Concerns

    Franck's Lab Inc. is recalling two units of Budesonide nasal irrigation solution because FDA testing found microorganisms in the production clean room.

    Product
    BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFERENT UNITS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1576-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs containing methylprednisolone and lidocaine because environmental sampling found microorganisms and fungal growth in the clean room.

    Product
    METHYLPREDNISOLONE ACETATE/LIDOCAINE HCL 40MG/10MG/ML INJECTABLE 100 ML 500 ML; METHYLPREDNISOLONE/LIDOCAINE 80MG/10MG/ML INJECTABLE 24 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1567-2012·2012-08-22

    Franck's Lab Recalls Sterile L-Tryptophan Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile L-Tryptophan injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    L-TRYPTOPHAN 15MG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1524-2012·2012-08-22

    Franck's Lab Recalls Forskolin/Phentolamine Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Forskolin/Phentolamine injectable units because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.

    Product
    FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1598-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPHTHA 10 ML 2 ML 20 ML 3 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1615-2012·2012-08-22

    Franck's Lab Recalls Sterile Selenium Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile selenium injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1600-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1549-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the preparation clean room.

    Product
    IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1591-2012·2012-08-22

    Franck's Lab Recalls Sterile Paclitaxel Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Paclitaxel injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1507-2012·2012-08-22

    Franck's Lab Recalls Sterile DMSO Heparin Methyldnisolone Solution Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile DMSO/Heparin/Methylprednisolone solution because FDA sampling found microorganisms and fungal growth in the clean room where the products were prepared.

    Product
    DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1572-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 200 ML 30 ML 50 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (M) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 150 ML 180 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1612-2012·2012-08-22

    Ranitidine Injectable Recalled Due to Sterility Assurance Failures

    Franck's Lab Inc. is recalling Ranitidine 25mg/mL injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    RANITIDINE 25MG/ML INJECTABLE 200 ML 480 ML 800 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1624-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs, including Theracys, because FDA testing found microorganisms and fungal growth in the clean room where the products were prepared.

    Product
    THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS 2 VIALS 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 6 VIAL 6 VIALS
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1565-2012·2012-08-22

    Franck's Lab Recalls Sterile Lithium Chloride Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile lithium chloride injectable products distributed between November 2011 and May 2012 because FDA testing found microorganisms in the clean room.

    Product
    LITHIUM CHLORIDE 5MG/ML INJECTABLE 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1553-2012·2012-08-22

    Labetalol Hydrochloride Injectable Recalled for Sterility Assurance Issues

    Franck's Lab Inc. is recalling Labetalol Hydrochloride 5mg/mL injectable products due to microorganisms and fungal growth found in the clean room.

    Product
    LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE 100 ML 80 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1526-2012·2012-08-22

    Franck's Lab Recalls Sterile Ganciclovir Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Ganciclovir injectable syringes because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.

    Product
    GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1500-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1502-2012·2012-08-22

    Franck's Lab Recalls Sterile Diclofenac Sodium Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile diclofenac sodium injectables distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.

    Product
    DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2 ML, 4 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1516-2012·2012-08-22

    Franck's Lab Recalls Sterile Ethyl Alcohol Injections Due to Contamination

    Franck's Lab Inc. is recalling sterile ethyl alcohol injections because FDA sampling found microorganisms and fungal growth in the production clean room.

    Product
    ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40 ML, 5 ML, 60 ML; ETHYL ALCOHOL 20% INJECTABLE 5 ML; ETHYL ALCOHOL 5% INJECTABLE 180 ML, 30 ML; ETHYL ALCOHOL 95% INJECTABLE 10 ML, 8 ML; ETHYL ALCOHOL OPHTHALMIC 40% INJECTABLE 50 ML (13 DI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1554-2012·2012-08-22

    Franck's Lab Recalls Sterile L-Arginine Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile L-Arginine 500mg/mL injectable products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.

    Product
    L-ARGININE 500MG/ML INJECTABLE 2500 ML 500 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1608-2012·2012-08-22

    Franck's Lab Recalls Sterile Progesterone Injections Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile progesterone injections distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the production clean room.

    Product
    PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 200 ML; PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 1000 ML; PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 10 MLS 30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1589-2012·2012-08-22

    Franck's Lab Recalls Ondansetron Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling 16 units of Ondansetron HCL injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE 200 ML 40 ML 400 ML 48 ML 600 ML 800 ML; ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE 20 ML 200 ML 24 ML 40 ML 48 ML (11 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1597-2012·2012-08-22

    Phentolamine Injectable Recall Due to Sterility Assurance Failure

    Franck's Lab Inc. is recalling Phentolamine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    PHENTOLAMINE 10MG/ML INJECTABLE 6 ML; PHENTOLAMINE 1MG/ML INJECTABLE 2 ML 5 ML; PHENTOLAMINE 5MG/ML INJECTABLE 20 ML 50 ML (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1570-2012·2012-08-22

    Recall of Mepivacaine Injectable Due to Sterility Assurance Failure

    Franck's Lab Inc. is recalling sterile Mepivacaine HCL injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MEPIVACAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 30 ML 60 ML; MEPIVICAINE HCL 3% (30MG/ML) INJECTABLE 6 MLS (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1536-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.

    Product
    HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE/LIDOCAINE/EPI/BUPIVICAINE INJECTABLE 32 ML, 64 ML (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1574-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms in the production clean room.

    Product
    METHYLCOBALAMIN/FOLIC ACID - KIT 10MG/0.4MG/ML INJECTABLE 1 KIT METHYLCOBALAMIN/FOLIC ACID 1000MCG/0.4MG/ML INJECTABLE 10 ML METHYLCOBALAMIN/FOLIC ACID 10MG/0.4MG/ML INJECTABLE 10 ML 8 ML 8 MLS
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1603-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORMAL SALINE 40MEQ/100ML (400MEQ/L) INJECTABLE 1000 ML; POTASSIUM CHLORIDE**(25X20ML) 2MEQ/ML INJECTABLE 500 ML; POTASSIUM PHOSPHATE 4.4MEQ/ML (3MMOL/ML) INJECTABLE 300 ML 750 ML (5 DIF
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1563-2012·2012-08-22

    Franck's Lab Recalls Lidocaine/Tetracaine Ophthalmic Solution Due to Sterility Concerns

    Franck's Lab Inc. is recalling Lidocaine/Tetracaine Ophthalmic Solution because FDA testing found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.

    Product
    LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML 400 ML (7 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1592-2012·2012-08-22

    Franck's Lab Recalls Sterile Pantothenic Acid Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile pantothenic acid injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PANTOTHENIC ACID 1MG/ML INJECTABLE 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1503-2012·2012-08-22

    Franck's Lab Recalls Sterile Diphenhydramine Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile diphenhydramine injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML, 90 MLS; DIPHENHYDRAMINE, SDV, 25X1ML** 50MG/ML INJECTABLE 25 ML (11 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1550-2012·2012-08-22

    Franck's Lab Recalls Isosulfan Blue Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Isosulfan Blue 1% Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    ISOSULFAN BLUE 1% INJECTABLE 10 ML 15 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1582-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MITOMYCIN/BUPIVACAINE WITH EPI 1:200,000 0. 04MG/0.5% PER 0.3ML SYR INJECTABLE 3 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1533-2012·2012-08-22

    Recall of Sterile Hyaluronic Acid Sodium Salt Injectable Drugs

    Franck's Lab Inc. is recalling sterile hyaluronic acid sodium salt injectable drugs due to the presence of microorganisms and fungal growth in the clean room.

    Product
    HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SALT, P.F. 20MG/ML INJECTABLE 500 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1557-2012·2012-08-22

    Franck's Lab Recalls Levothyroxine Sodium Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Levothyroxine Sodium Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    LEVOTHYROXINE SODIUM 325MCG/ML (0.325MG/ML) INJECTABLE 15 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1471-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Drug Mixtures Due to Contamination

    Franck's Lab Inc. is recalling sterile intrathecal drug mixtures because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 5MG/500MCG/50MG/ML INTRATHECAL (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1527-2012·2012-08-22

    Franck's Lab Recalls Sterile G-C-P Solutions Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile G-C-P solutions because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.

    Product
    G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1578-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MEYERS COCKTAIL INJECTABLE 30 ML; MEYERS COCKTAIL (DR. MORENO) INJECTABLE 90 ML; MEYERS COCKTAIL/ CALCIUM/VIT B1/ METHYLCOBALAMIN 1GM/5MG/1000MCG/500ML INJECTAB 250 ML 5 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1641-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Vitamins Due to Sterility Concerns

    Franck's Lab Inc. is recalling 23 sterile injectable vitamin products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K (PHYTONADIONE) 5MG/ML INJECTABLE 2 ML; VITAMIN A AQUEOUS EMULSION 50,000 U/ML INJECTABLE 20 ML 40 ML; VITAMIN B COMPLEX (B1,B2,B3,B5,B6) 100/5/100/100/100MG/ML INJECTABLE 120 ML 150 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1519-2012·2012-08-22

    Franck's Lab Recalls Sterile Fluorescein/Indocyanine Drugs Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile Fluorescein/Indocyanine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1458-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML, 5 ML (8 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1451-2012·2012-08-22

    Franck's Lab Recalls Sterile Aflibercept Syringes Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Aflibercept syringes distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML, 1.25 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1509-2012·2012-08-22

    Franck's Lab Recalls Sterile Doxorubicin HCL Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Doxorubicin HCL vials because FDA sampling found microorganisms and fungal growth in the clean room where the drugs were prepared.

    Product
    DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 2 VIAL; DOXORUBICIN HCL, LYOPHILIZED 50MG VIAL 1 VIAL, 10 VIAL, 5 VIAL (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1604-2012·2012-08-22

    Franck's Lab Recalls Povidone-Iodine Ophthalmic Solutions Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific povidone-iodine ophthalmic solutions because FDA testing found microorganisms in the production clean room.

    Product
    POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC 100 ML 120 ML 200 ML (8 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1548-2012·2012-08-22

    Franck's Lab Recalls Iohexol Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling 19 units of Iohexol injectable sterile drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    IOHEXOL 200MG IODINE/ML INJECTABLE 120 ML 300 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (10 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1479-2012·2012-08-22

    Franck's Lab Recalls Sterile Bupivacaine/Sufentanil Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile bupivacaine/sufentanil injections because FDA sampling found microorganisms and fungal growth in the production clean room.

    Product
    BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1464-2012·2012-08-22

    Franck's Lab Recalls Sterile Bevacizumab Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile bevacizumab injectables and ophthalmic products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 3 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.075ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.225 ML; BEVACIZU
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1642-2012·2012-08-22

    Franck's Lab Recalls Sterile Voriconazole Ophthalmic Drugs Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile voriconazole ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    VORICONAZOLE OPHTHALMIC 1% (10MG/ML) SOLUTION 15 ML; VORICONAZOLE OPHTHALMIC, (0.5ML, LL SYRINGE), P.F. 0.1% (100MCG/0.1ML) INJECTABL 0.5 ML 1 ML 1.5 ML 2 ML 2.5 ML 5 ML; VORICONAZOLE OPHTHALMIC, P.F. (SINGLE DOSE ONLY) 0.1% (100MCG/0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1623-2012·2012-08-22

    Franck's Lab Recalls Sterile Tetracosactide Acetate Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile Tetracosactide Acetate injectables distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1555-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Leucovorin Vials Due to Microbial Contamination

    Franck's Compounding Lab is recalling sterile leucovorin vials because FDA environmental sampling found microorganisms and fungal growth in the clean room where the products were prepared.

    Product
    LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30 VIAL 50 VIAL 60 VIAL 76 VIAL; LEUCOVORIN, LYOPHILIZED 350 MG VIAL INJECTABLE 10 VIAL 15 VIAL 20 VIAL 22 VIAL 28 VIAL 30 VIAL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1484-2012·2012-08-22

    Franck's Lab Recalls Sterile Chromium Picolinate Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile chromium picolinate injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1462-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Baclofen and Morphine Mixtures

    Franck's Lab Inc. is recalling sterile intrathecal Baclofen/Morphine mixtures distributed between November 2011 and May 2012 due to microbial contamination found in the clean room.

    Product
    BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPHINE, P.F. 2,000MCG/25MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1529-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile glutathione products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.

    Product
    GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300 ML, 40 ML, 40 MLS, 50 ML, 58 MLS, 70 ML; GLUTATHIONE P.F. 50MG/ML (500MG/10ML) INJECTABLE 100 ML, 150 ML, 20 ML, 40 ML, 60 ML;
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1501-2012·2012-08-22

    Franck's Lab Recalls Sterile Diazepam Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile diazepam injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300 ML; DIAZEPAM 2.5MG/ML INJECTABLE 40 ML; DIAZEPAM 2MG/ML INJECTABLE 100 ML, 50 ML (8 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1546-2012·2012-08-22

    Franck's Compounding Lab Recalls Indocyanine Green Injectable Kits Due to Sterility Concerns

    Franck's Compounding Lab is recalling Indocyanine Green injectable kits because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.

    Product
    INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1461-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Baclofen and Hydromorphone Mixtures

    Franck's Lab Inc. is recalling sterile intrathecal drug mixtures due to microorganisms and fungal growth found in the clean room.

    Product
    BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/HYDROMORPHONE, P.F. 500MCG/50MG/ML INTRATHECAL 40 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1552-2012·2012-08-22

    Recall of Sterile Ketorolac Tromethamine Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ketorolac tromethamine injectable products because environmental sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 ML; KETOROLAC TROMETHAMINE, 1ML SDV**25X1ML 30MG/ML INJECTABLE 50 ML 75 ML; KETOROLAC TROMETHAMINE, P.F. 60MG/ML INJECTABLE 10 ML (7 DIFFERENT PRODU
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1640-2012·2012-08-22

    Franck's Lab Recalls Sterile Verapamil Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Verapamil HCL injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    VERAPAMIL HCL 10MG/ML INJECTABLE 80 ML; VERAPAMIL HCL 20MG/ML INJECTABLE 50 ML; VERAPAMIL HCL, SDV*** (5X2ML VIAL) 2.5MG/ML INJECTABLE 20 MLS 40 ML 50 ML 50 MLS (6 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1609-2012·2012-08-22

    Franck's Lab Recalls Pyridoxine Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Pyridoxine 100mg/mL Injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1566-2012·2012-08-22

    Franck's Lab Recalls Lorazepam Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Lorazepam 2mg/mL injectable products because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    LORAZEPAM 2MG/ML INJECTABLE 10 ML 20 ML 200 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1614-2012·2012-08-22

    Franck's Lab Recalls Sterile Rubidium Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Rubidium 200mcg/mL injectable products distributed between November 2011 and May 2012. The recall was initiated after FDA sampling found microorganisms and fungal growth in the clean room used for preparation.

    Product
    RUBIDIUM 200MCG/ML INJECTABLE 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1544-2012·2012-08-22

    Franck's Lab Recalls Hydroxyprogesterone Caproate Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling 48 units of Hydroxyprogesterone Caproate Injectable because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.

    Product
    HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML, 12 ML, 13 ML, 15 ML, 3 ML, 30 ML, 4 ML, 5 ML, 6 ML, 7 ML, 9 ML (11 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1596-2012·2012-08-22

    Recall of Penicillin G Potassium Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Penicillin G Potassium Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    PENICILLIN G POTASSIUM 10,000U/ML INJECTABLE 1 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1622-2012·2012-08-22

    Franck's Lab Recalls Sterile Tetracaine Ophthalmic Solutions Due to Contamination

    Franck's Lab Inc. is recalling sterile tetracaine ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.

    Product
    TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML 6 ML; TETRACAINE HCL P.F. OPHTHALMIC 0.5% SOLUTION 30 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1540-2012·2012-08-22

    Franck's Lab Recalls Sterile Hydromorphone Products Due to Microbial Contamination

    Franck's Lab Inc. is recalling four sterile hydromorphone products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 30MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 50MG/ML INTRATHECAL 40 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1449-2012·2012-08-22

    Franck's Lab Recalls Acetylcysteine Ophthalmic Solutions Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific acetylcysteine ophthalmic solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% SOLUTION 20 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 5% SOLUTION 3 ML (6 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2012.