The Recall Desk

FDA (Drugs) recall action 62443

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled 98 products on 2012-08-22

The FDA (Drugs) publishes a recall like this one as 98 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 98 pages.

Products
98
Announced
2012-08-22
Critical
0
Units
6,766

Why these products were recalled

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–50 of 98

  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sterile Papaverine HCL Injectable Due to Sterility Concerns

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

    Product
    PAPAVERINE HCL **(10ML VIAL) 30MG/ML INJECTABLE 10 ML 100 ML (2 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sterile Human 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
    SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML; SODIUM BICARBONATE 8.4% INJECTABLE 150 ML 50 ML 5000 ML; SODIUM BICARBONATE, 50ML SDV** 8.4% (1MEQ/ML) INJECTABLE 100 MLS 250 ML; SODIUM BICARBONATE, MDV 8.4% INJECTABLE 100 ML 150 ML 200 ML; SODIUM CHLORIDE 0
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

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

    Product
    THIOTEPA, LYOPHILIZED 15MG INJECTABLE 8 VIAL; THIOTEPA, LYOPHILIZED 30MG INJECTABLE 4 VIAL 8 VIAL; THIOTEPA, LYOPHILIZED 60MG INJECTABLE 2 VIAL (4 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

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

    Product
    TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION** 0.3% OPHTHALMIC 30 MLS 5 MLS; TOBRAMYCIN SULFATE** (25X2ML) 80MG/2ML INJECTABLE 100 ML 150 ML 50 MLS; TOBRAMYCIN/AMPHOTERICIN-B/BUDESONIDE, STERILE 125MG/5MG/0.6MG/5ML NASO-NEB 70
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Strontium Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Strontium 1 mg/mL Injectable due to microorganisms found in the clean room where sterile products were prepared.

    Product
    STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    PAPAVERINE/PHENTOLAMINE/ATROPINE NS 3.6MG/0.4MG/0.04MG INJECTABLE 13 ML (1 PRODUCT)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

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

    Product
    ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML 10 ML
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sterile Mitomycin Drugs Due to Contamination

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

    Product
    MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML; MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC 0.5 ML 1 ML 1.5 ML 10 ML 12.5 ML 2 ML
    Category
    Distribution
    0 states