Drug and pharmaceutical recalls

17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2016-06-15FDA-DrugWell Care Compounding PharmacyClass II
ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
2016-06-15FDA-DrugWell Care Compounding PharmacyClass II
ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
2016-06-15FDA-DrugWell Care Compounding PharmacyClass II
ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
2016-06-15FDA-DrugWell Care Compounding PharmacyClass II
ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
2016-06-15FDA-DrugWell Care Compounding PharmacyClass II
ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
2016-06-15FDA-DrugWell Care Compounding PharmacyClass II
ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
2016-06-15FDA-DrugWell Care Compounding PharmacyClass II
17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
2016-06-15FDA-DrugBayer Health Care LLCClass II
Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762
Labeling; Product Contains Undeclared API (Oxybenzone)
2016-06-15FDA-DrugPharmedium Services, LLCClass II
Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836.
Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
2016-06-15FDA-DrugAidarex Pharmaceuticals LLCClass II
CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
2016-06-15FDA-DrugAidarex Pharmaceuticals LLCClass III
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
2016-06-15FDA-DrugNovacare, LLCClass I
Xcellerator (product not labeled)
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers. TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
TruTrim (product not labeled)
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store 2050 E. 6200 S., Holladay, UT 84121, The Store Holliday, 4695 S.Holladay Blvd, Holladay, UT 84117, The Store Midway, 42 W. Main Street, Midway, UT 84049.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers. http://www.secretsofherbs.com. Made in the USA.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers. www.metapro360.com 877-778-7509.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers. Manufactured by TPC, LLC, www.thepeopleschemist.com.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugNovacare, LLCClass I
Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
2016-06-15FDA-DrugReesna, IncClass I
FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
2016-06-15FDA-DrugReesna, IncClass I
FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
2016-06-15FDA-DrugBaxter Healthcare Corp.Class I
Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
2016-06-15FDA-DrugBaxter Healthcare Corp.Class I
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
2016-06-15FDA-DrugNovo Nordisk IncClass II
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
2016-06-08FDA-DrugLupin Pharmaceuticals Inc.Class III
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.

← prevpage 397/592next →

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

Get notified about new drug recalls

Explore other recall topics