D-1255-2020 Class I Terminated

Recalled by Avet Pharmaceuticals, Inc. — East Brunswick, NJ

FDA drug recall D-1255-2020 was initiated by Avet Pharmaceuticals, Inc. on March 23, 2020 and is designated Class I. Reason for recall: Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules. The recall status is terminated (terminated August 23, 2022). Affected quantity: 4,444 bottles.

Recall Details

Product Type
Drugs
Report Date
April 15, 2020
Initiation Date
March 23, 2020
Termination Date
August 23, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,444 bottles

Product Description

Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01

Reason for Recall

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

Distribution Pattern

Distributed Nationwide in the US

Code Information

Lot # H190666, Exp JUL 2022