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.

26–50 of 198

  • 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-1583-2012·2012-08-22

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

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

    Product
    MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.04%/0.02%/0.1% INJECTABLE 5 ML; MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.08MG/13.3MG/6.7MCG/ML INJECTABLE 0.2 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1506-2012·2012-08-22

    Franck's Lab Recalls Sterile DMSO and Heparin Solutions Due to Contamination

    Franck's Lab Inc. is recalling specific sterile DMSO and Heparin solutions because FDA testing found microorganisms and fungal growth in the production clean room.

    Product
    DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML SOLUTION 300 ML, 400 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1477-2012·2012-08-22

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

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

    Product
    BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML; BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.22% / 0.88% / 0.88% INJECTABLE 450 ML, 900 ML (7 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1629-2012·2012-08-22

    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
    TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML; TRIMIX 9MG / 0.3MG /6.6MCG INJECTABLE 6 ML; TRIMIX 9MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 2ML VIAL 30MG / 1MG / 10MCG INJECTABLE 10 ML 10 VIALS 2 ML 4 ML 50 ML; TRIMIX ((LYOPHILIZ
    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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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