Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-04-25FDA-DrugPartell Specialty PharmacyClass IITM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 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 IITestosterone Cypionate 200mg/mL, 5 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 IINandrolone decanoate 200mg/mL, 5 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 IIMethionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL 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 IIMethionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 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 IILipoic Acid 25mg/mL, 5 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 IIHCG 1000 units/mL, packaged in a) 2 mL and b) 6 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 IIGlutathione 200mg/mL, 10mL 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 IICoEnzymeQ10 25mg/mL, 5mL 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 IIBiotin Suspension 10mg/mL, 5 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 IIB-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 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 IIAscorbic Acid (Tapioca) 500 mg/mL, 50 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-DrugAVKARE Inc.Class IIAmantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
Failed Dissolution Specifications
- 2018-04-25FDA-DrugPharmedium Services, LLCClass IIIVasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478
cGMP deviations
- 2018-04-25FDA-DrugSandoz IncorporatedClass IIITriamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
- 2018-04-25FDA-DrugDiamond Wipes International, Inc.Class IIWipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6.
CGMP Deviations: finished products were manufactured with poor quality water.
- 2018-04-25FDA-DrugDiamond Wipes International, Inc.Class IIACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL 33316, UPC 8 54049 00358 0.
CGMP Deviations: finished products were manufactured with poor quality water.
- 2018-04-25FDA-DrugMarcas Usa LlcClass IIPASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111-60
Microbial Contamination of Non-Sterile Products
- 2018-04-25FDA-DrugNoven Pharmaceuticals, Inc.Class IIDaytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
Defective Delivery System: Out of specification for adhesive transfer.
- 2018-04-18FDA-DrugInvaGen Pharmaceuticals, Inc.Class IIIDecitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
Failed impurities/degradation specifications: Failure to water content and impurity
- 2018-04-18FDA-DrugLake Erie Medical & Surgical Supply IncClass IIITramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2018-04-18FDA-DrugUnited Pacific Co LtdClass IIZhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
- 2018-04-18FDA-DrugElroselabs Inc.Class IIConzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL
cGMP Deviations
- 2018-04-18FDA-DrugElroselabs Inc.Class IIMolleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc.
cGMP Deviations
- 2018-04-18FDA-DrugElroselabs Inc.Class IIConzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06
cGMP Deviations
- 2018-04-11FDA-DrugInvaGen Pharmaceuticals, Inc.Class IIIbuPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
Failed Dissolution Specifications; during stability testing
- 2018-04-11FDA-DrugInvaGen Pharmaceuticals, Inc.Class IIIbuPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
Failed Dissolution Specifications; during stability testing
- 2018-04-11FDA-DrugMayne Pharma IncClass IIIFabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
- 2018-04-04FDA-DrugJimmy WeberClass IRed Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021
Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
- 2018-04-04FDA-DrugApollo CareClass IIVancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
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