Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-05-02FDA-DrugTime-Cap Laboratories, Inc.Class IIIbuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- 2018-05-02FDA-DrugTime-Cap Laboratories, Inc.Class IIIbuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- 2018-05-02FDA-DrugTime-Cap Laboratories, Inc.Class IIIbuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- 2018-05-02FDA-DrugTime-Cap Laboratories, Inc.Class IIIbuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- 2018-04-25FDA-DrugRenaissance Lakewood, LLCClass IIFluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
- 2018-04-25FDA-DrugLupin Pharmaceuticals Inc.Class IILupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
Superpotent Drug
- 2018-04-25FDA-DrugLEADIANT BIOSCIENCES, INCClass IIICystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IIEstradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IIEstradiol 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IIEstradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IIEstradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IIEstradiol 25 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IIEstradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IIEstradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IIEstradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IIEstradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone/Anastrozole 200 mg/20 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone 55 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone 50 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone 100 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITestosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
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