Drug and pharmaceutical recalls
17733 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIAlprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIAlprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIAlprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIAlprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIAcetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIAcetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIAcetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass II5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass II5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugNovartis Pharmaceuticals Corp.Class IIIDexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
- 2015-09-23FDA-DrugAkorn, Inc.Class IIIIC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
Subpotent Drug: Low out-of-specification potency result of the drug product.
- 2015-09-23FDA-DrugHospira Inc.Class IIKetamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05
Defective Container: There were customer complaints of cracked and leaking glass vials.
- 2015-09-16FDA-DrugPharmedium Services, LLCClass IIRopivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
- 2015-09-16FDA-DrugHealthpoint, LtdClass IISurgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza Brooks City-Base, Texas 78235. NDC: 0064-1080-11
Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
- 2015-09-16FDA-DrugGolden State Medical Supply Inc.Class IIIMETHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05.
Presence of Foreign Substance: Presence of hair.
- 2015-09-16FDA-DrugMutual Pharmaceutical Company, Inc.Class IIIImipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01
Chemical Contamination; benzophenone leached from the product label varnish
- 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.
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief