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.

76–98 of 98

  • SevereFDA (Drugs)··2012-08-22

    Franck's Compounding Lab Recalls Sterile Vancomycin Eye Drops

    Franck's Compounding Lab is recalling sterile vancomycin eye drops and injections due to microbial contamination found in the facility's clean room.

    Product
    VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. (BSS) 0.4% (4MG/ML) (0.4MG/0.1ML) INJE 400 ML; VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. 1MG/0.1ML (10MG/ML) INJECTABLE 0.1 ML 0.2 ML 1 ML 100 ML 150 ML 2 ML 2 MLS 5 ML 50 ML 6 ML
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TWINJECT*** 0.3 MG INJECTABLE 1 PK (1 PRODUCT)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sterile Vancomycin and Dexamethasone Kits Due to Contamination

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

    Product
    VANCOMYCIN/DEXAMETHASONE, LYOPHILIZED 1%/0.1% KIT 2 KIT 20 KIT 24 KIT (3 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Moxifloxacin Injectable Due to Sterility Concerns

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

    Product
    MOXIFLOXACIN 150MCG/0.1ML (1.5MG/ML) INJECTABLE 10 ML 20 ML (2 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    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 human drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TROPICAMIDE OPHTHALMIC P.F. 1% SOLUTION 30 ML (1 PRODUCT)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs, including nandrolone decanoate, after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sterile Lidocaine and Epinephrine Injectable Drugs

    Franck's Lab Inc. is recalling sterile lidocaine and epinephrine injectable drugs due to the presence of microorganisms and fungal growth in the clean room where they were prepared.

    Product
    LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE 24 ML 6 ML; LIDOCAINE HCL/EPINEPHRINE, P.F., SULFITE-FREE 2%/1:100,000 (0.001%) INJECTABLE 10 ML 40 ML; LIDOCAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 100 ML 12
    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
    TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 ML 576 ML 90 ML (5 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Lab Recalls Sermorelin Acetate Due to Sterility Concerns

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

    Product
    SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

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

    Product
    LEVOFLOXACIN, P.F. (PREMIXED SOLUTION) 5MG/ML INJECTABLE 1200 ML 500 ML 700 ML 800 ML LEVOFLOXACIN, P.F. 25MG/ML(500MG/20ML) INJECTABLE 300 ML 500 ML (6 DIFFERENT PRODUCTS)
    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 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    POVIDONE-IODINE/LIDOCAINE/TETRACAINE 4.6%/4%/0.5% OPHTHALMIC 30 ML (1 PRODUCT)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

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

    Product
    OXYTOCIN 10UNITS/ML INJECTABLE 25 ML; OXYTOCIN**(25X1ML) 10U/ML INJECTABLE 25 MLS (2 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

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

    Product
    METHYLPREDNISOLONE ACETATE 100MG/ML INJECTABLE 50 ML; METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE 1 ML 30 ML 6 ML 60 ML (5 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

    Franck's Lab Inc. is recalling sterile Mannitol injectable drugs because FDA testing found microorganisms and fungal growth in the manufacturing clean room.

    Product
    MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MANNITOL 25% INJECTABLE 1200 ML 300 ML 350 ML 400 ML 600 ML (9 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

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

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

    Product
    MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2012-08-22

    Franck's Compounding Lab Recalls Sterile Ophthalmic Drug Mixtures

    Franck's Compounding Lab is recalling sterile ophthalmic drug mixtures due to the presence of microorganisms and fungal growth in the clean room where they were prepared.

    Product
    LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.00025%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.0005%/0.25% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML (8 DIFFERENT PRODUCTS)
    Category
    Distribution
    0 states