The Recall Desk

FDA (Drugs) recall action 62416

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled 100 products on 2012-08-22

The FDA (Drugs) publishes a recall like this one as 100 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 100 pages.

Products
100
Announced
2012-08-22
Critical
0
Units
5,995

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 because 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.

76–100 of 100

  • SevereFDA (Drugs)··2012-08-22

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

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

    Product
    EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML; EDTA CALCIUM DISODIUM SOLUTION 2% OPHTHALMIC 5 ML; EDTA DISODIUM (P.F.) 150MG/ML INJECTABLE 1000 ML, 1200 ML, 1500 ML, 400 ML,
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Morphine Sulfate Mixtures

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

    Product
    BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 35 ML (4 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

    Franck's Lab Inc. is recalling 73 sterile dexamethasone products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECTABLE 30 MLS; DEXAMETHASONE ACETATE (LA) 8MG/ML INJECTABLE 100 ML; DEXAMETHASONE IONTOPHORESIS, STERILE, P.F. 4MG/ML SOLUTION 20 ML, 30 ML (35 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 448 units of BIMIX sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG / 1MG INJECTABLE 10 ML; BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 18MG / 1MG INJECTABLE 5 ML; BIMIX 20MG / 0.75MG INJECTABLE 5 ML; BI
    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 in the production clean room.

    Product
    BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sterile Clindamycin Eye and Injectable Products

    Franck's Lab Inc. is recalling sterile clindamycin eye and injectable products due to microorganisms and fungal growth found in the clean room.

    Product
    CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE OPHTHALMIC, INTRAVITREAL (P.F.) 1MG/0.1ML INJECTABLE 0.2 ML; CLINDAMYCIN PHOSPHATE SDPF- (0.1ML SYRINGE,30G,1/2") 1MG/0.1ML INJECTABLE 0.1 ML (3 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

    Franck's Lab Inc. is recalling Dapiprazole ophthalmic products because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5% POWDER 1 KIT, 10 KIT, 2 KIT, 3 KIT, 4 KIT, 6 KIT (7 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Furosemide Injectable Recall Due to Sterility Assurance Issues

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

    Product
    FUROSEMIDE*** (25X10ML) 10MG/ML INJECTABLE 250 ML; FUROSEMIDE*** (25X4ML) 10MG/ML INJECTABLE 2 VIAL (2 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sterile Injectable Solutions Due to Contamination

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

    Product
    HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

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

    Product
    BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 ML (1 PRODUCT)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Baclofen Due to Sterility Concerns

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

    Product
    BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MCG/ML INTRATHECAL 40 ML; BACLOFEN, P.F. 1,000MCG/ML (1MG/ML) INTRATHECAL 20 ML, 40 ML; BACLOFEN, P.F. 500MCG/ML (0.5MG/ML) INTRATHECAL 40 ML; B
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Recall of Sterile Alteplase Syringes Due to Microbial Contamination

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

    Product
    ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (10MCG/0.1ML) INJECTA 0.15 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML; ALTEPLASE, SD
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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 testing found microorganisms in the production clean room.

    Product
    BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIVACAINE/MORPHINE, P.F. 500MCG/1/7.5/50MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUC
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

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

    Product
    CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC 20 ML (1 PRODUCT)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Recall of Boron Injectable Due to Sterility Assurance Failure

    Franck's Lab is recalling Boron 2mg/mL Injectable because FDA sampling found microorganisms in the clean room where sterile products were prepared.

    Product
    BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

    Franck's Lab Inc. is recalling 72 units of sterile estradiol products distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL 50MG PELLETS 1 PELELT, 1 PELLET, 4 PELLET, 6 PELLET; ESTRADIOL CYPIONATE 5MG/ML INJECTABLE 5 ML; ESTRADIOL VALERATE IN COTTONSEED OIL 40 MG/ML INJECTABLE 10 ML; ES
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Recall of Hydrochloric Acid Injection Due to Sterility Concerns

    Franck's Lab Inc. is recalling Hydrochloric Acid Injection products because FDA testing found microorganisms in the production clean room.

    Product
    HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 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 19 units of sterile injectable drugs, including ascorbic acid and vitamin blends, because FDA sampling found microorganisms in the production clean room.

    Product
    ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 60 ML; ASCORBIC ACID (CORN SOURCE) 500MG/ML INJECTABLE 100 ML; ASCORBIC ACID, 50ML SDPF, VIAL** 500MG/ML INJECTABLE 50 ML, 500 ML; ASCORBIC/B1/B2/B3/B5/B6/B12/METHIONINE/INOSIT
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sterile Sodium Chloride Vials Due to Microbial Contamination

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

    Product
    BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20 MLS, 200 ML, 30 MLS, 40 ML, 50 ML, 50 MLS (10 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Dexpantenol Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Dexpantenol 250mg/ml Injectable products because FDA testing found microorganisms in the production clean room.

    Product
    DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states