Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-09-16FDA-DrugMutual Pharmaceutical Company, Inc.Class IIIImipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
Chemical Contamination; benzophenone leached from the product label varnish
- 2015-09-16FDA-DrugMutual Pharmaceutical Company, Inc.Class IIIImipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
Chemical Contamination; benzophenone leached from the product label varnish
- 2015-09-16FDA-DrugMutual Pharmaceutical Company, Inc.Class IIIFelodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
Chemical Contamination; benzophenone leached from the product label varnish
- 2015-09-16FDA-DrugMutual Pharmaceutical Company, Inc.Class IIIFelodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
Chemical Contamination; benzophenone leached from the product label varnish
- 2015-09-16FDA-DrugMutual Pharmaceutical Company, Inc.Class IIIFelodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01
Chemical Contamination; benzophenone leached from the product label varnish
- 2015-09-16FDA-DrugBestco, Inc.Class IIICVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895.
Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
- 2015-09-16FDA-DrugOasis Medical, Inc.Class IIIImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05
Falied pH specification
- 2015-09-16FDA-Drug3M Company - Health Care BusinessClass IIDuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0 03 17518 01108 5) and b) 0.2 fl oz, 6 mL Single Use Applicator w/urethane sponge per pouch, packaged in 50 pouches per case (NDC 17518-0011-07, UPC (01) 0 03 17518 01107 8), OTC, Mad
Chemical contamination: Product may be contaminated with a toxic compound.
- 2015-09-09FDA-DrugSilarx Pharmaceutical, Inc.Class IIILamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIBi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIBi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIEstradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIBi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIEstriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIBi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIEstradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIEstradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IITri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugVintage Pharmaceuticals LLC dba Qualitest PharmaceuticalsClass IILisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811
Failed Dissolution Specifications
- 2015-09-09FDA-DrugQualitest PharmaceuticalsClass IIIALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIMethyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIChorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIArtesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIMeloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IILeucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-09FDA-DrugSouth Coast Specialty Compounding, Inc.Class IIBi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
- 2015-09-02FDA-DrugLiberty Drug & SurgicalClass IIMethylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- 2015-09-02FDA-DrugLiberty Drug & SurgicalClass IILidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- 2015-09-02FDA-DrugLiberty Drug & SurgicalClass IIHydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- 2015-09-02FDA-DrugLiberty Drug & SurgicalClass IIDoxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
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