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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 8501–8520 of 17,773 recalls

Class IITerminated

Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

AVKARE Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 14, 2018 · DrugView details →

Class IITerminated

Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

AVKARE Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 14, 2018 · DrugView details →

Class IIITerminated

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer

August 14, 2018 · DrugView details →

Class IIITerminated

Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30

Jubilant Cadista Pharmaceuticals, Inc.

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

August 14, 2018 · DrugView details →

Class IIITerminated

Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90

Jubilant Cadista Pharmaceuticals, Inc.

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

August 14, 2018 · DrugView details →

Class IIITerminated

Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90

Jubilant Cadista Pharmaceuticals, Inc.

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

August 14, 2018 · DrugView details →

Class IIITerminated

Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709

United Therapeutics Corp.

Defective Delivery System: Water ingress through the lower water cup sensor of the device.

August 14, 2018 · DrugView details →

Class IITerminated

Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

AVKARE Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 14, 2018 · DrugView details →

Class IITerminated

Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51

Mckesson Corporation

Supterpotent Drug

August 14, 2018 · DrugView details →

Class ITerminated

Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin Lakes, NJ 07417 www.LivingWellRemedies.com. Made in the USA

Living Well Remedies, LLC

Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.

August 13, 2018 · DrugView details →

Class IITerminated

Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03

Lupin Pharmaceuticals Inc.

Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.

August 13, 2018 · DrugView details →

Class IITerminated

Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92

Westlab Pharmacy, Inc. dba Westlab Pharmacy

Lack of Process Controls

August 10, 2018 · DrugView details →

Class IITerminated

Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19

RemedyRepack Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 10, 2018 · DrugView details →

Class IITerminated

ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05

Westlab Pharmacy, Inc. dba Westlab Pharmacy

Lack of Process Controls

August 10, 2018 · DrugView details →

Class IITerminated

Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19

RemedyRepack Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 10, 2018 · DrugView details →

Class IITerminated

Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00

Westlab Pharmacy, Inc. dba Westlab Pharmacy

Incorrect Product Formulation

August 10, 2018 · DrugView details →

Class IITerminated

Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19

RemedyRepack Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 10, 2018 · DrugView details →

Class IIITerminated

Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99.

Orexigen Therapeutics, Inc.

Defective Container: Customer complaints of punctures in the bottle.

August 9, 2018 · DrugView details →

Class IIITerminated

Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10

Akorn, Inc.

Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide

August 8, 2018 · DrugView details →

Class IICompleted

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902

Hetero Labs Limited Unit V

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 8, 2018 · DrugView details →

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