The Recall Desk

Manufacturer

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

198 recalls in our database name Franck's Lab Inc., d.b.a. Franck's Compounding Lab as the manufacturing or recalling firm.

What the numbers show

Total
198
Critical
0
Severe
198
Most recent
2012-08-22

Of the 198 recalls from Franck's Lab Inc., d.b.a. Franck's Compounding Lab we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 198 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

176–198 of 198

  • SevereFDA (Drugs)·D-1495-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1525-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1545-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1472-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1556-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1459-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1453-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1460-2012·2012-08-22

    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 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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1491-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1467-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1515-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1508-2012·2012-08-22

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

    Franck's Lab is recalling specific sterile eye drops because FDA testing found microorganisms and fungal growth in the production clean room.

    Product
    DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1539-2012·2012-08-22

    Franck's Lab Recalls Sterile Hydrogen Peroxide Injectable Due to Contamination

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

    Product
    HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1605-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1538-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1590-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1575-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1569-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1457-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1584-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1463-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1499-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1561-2012·2012-08-22

    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
    Drug
    Distribution
    Distributed nationwide