Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-05-03FDA-DrugNovartis Pharmaceuticals Corp.Class IIIPilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15
Failed Impurities/Degradation Specifications.
- 2017-05-03FDA-DrugNovartis Pharmaceuticals Corp.Class IIIIsopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15
Failed Impurities/Degradation Specifications.
- 2017-05-03FDA-DrugGary WoodClass IIhCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO
Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
- 2017-04-26FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IINystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
- 2017-04-26FDA-DrugInnovaGelClass IIIDye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284
Subpotent
- 2017-04-26FDA-DrugInnovaGelClass IIIDiphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284
Subpotent
- 2017-04-26FDA-DrugValeant Pharmaceuticals North America LLCClass IIICLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01
Discoloration.
- 2017-04-26FDA-DrugValeant Pharmaceuticals North America LLCClass IIICLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04
Discoloration.
- 2017-04-19FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIBuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- 2017-04-19FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIBuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- 2017-04-19FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIBuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- 2017-04-19FDA-DrugMckesson Medical SurgicalClass IIhydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
- 2017-04-19FDA-DrugAllergan Sales, LLCClass IIILumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.
Failed Impurities/Degradation Specifications
- 2017-04-19FDA-DrugMedisca, Inc.Class IIESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- 2017-04-19FDA-DrugMedisca, Inc.Class IIESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- 2017-04-19FDA-DrugMedisca, Inc.Class IIESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- 2017-04-19FDA-DrugMedisca, Inc.Class IIESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- 2017-04-19FDA-DrugSignature Club A LtdClass IIDouble Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate 5.15%, Avobenzone 3.09%), Net Wt. 1.8 oz. (51 g) jar, Distributed by Signature Club A, Ltd, Tampa, FL 33609.
Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
- 2017-04-19FDA-DrugAkorn, Inc.Class IILATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
- 2017-04-19FDA-DrugQinhuangdao Zizhu Pharmaceutical, Co.Class IILevonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),
cGMP Deviations; lack of quality assurance.
- 2017-04-19FDA-DrugQinhuangdao Zizhu Pharmaceutical, Co.Class IIEthinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05)
cGMP Deviations; lack of quality assurance.
- 2017-04-19FDA-DrugQinhuangdao Zizhu Pharmaceutical, Co.Class IITestosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)
cGMP Deviations; lack of quality assurance.
- 2017-04-19FDA-DrugQinhuangdao Zizhu Pharmaceutical, Co.Class IIEstrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
cGMP Deviations; lack of quality assurance.
- 2017-04-19FDA-DrugQinhuangdao Zizhu Pharmaceutical, Co.Class IIEstriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06
cGMP Deviations; lack of quality assurance.
- 2017-04-19FDA-DrugQinhuangdao Zizhu Pharmaceutical, Co.Class IIEstradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China
cGMP Deviations; lack of quality assurance.
- 2017-04-19FDA-DrugQinhuangdao Zizhu Pharmaceutical, Co.Class IIEstradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06)
cGMP Deviations; lack of quality assurance.
- 2017-04-19FDA-DrugNovel Laboratories, Inc.Class IIIFluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
Chemical Contamination
- 2017-04-19FDA-DrugCitron Pharma LlcClass IIIPenicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
- 2017-04-19FDA-DrugWest-Ward Columbus, Inc.Class IIIDoxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for West-Ward, Pharmaceuticals, Corp., Eatontown, NJ -- NDC 0054-0338-19
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
- 2017-04-12FDA-DrugLupin Pharmaceuticals Inc.Class IIIQuinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
Failed Impurities/Degradation Specifications; Impurity A
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