Recall Enforment Report D-1255-2020

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Avet Pharmaceuticals, Inc., originally initiated on 03-23-2020 for the product Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01 The product was recalled due to failed dissolution specifications: out of specification result during long term testing in tetracycline hcl capsules.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1255-202003-23-202004-15-2020Class I4,444 bottlesTetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.Terminated
D-1254-202003-23-202004-15-2020Class I17,524 bottlesTetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
23155-017Tetracycline Hydrochloride Tetracycline HydrochlorideCapsuleOralHeritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.Human Prescription Drug
23155-018Tetracycline Hydrochloride Tetracycline HydrochlorideCapsuleOralHeritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.Human Prescription Drug