Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01

FDA recall notice · announced April 15, 2020 · Avet Pharmaceuticals

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01

Reason for recall

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

Notes

Distribution: Distributed Nationwide in the US
Lot/code information: Lot #s: G190609, G190610, G190611, Exp Jun 2022: L191027, L191028, Exp Nov 2022: K190953, K190952, Exp Oct 2022
Quantity: 17,524 bottles
Status: Terminated
Products in this recall event:
- Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01 (D-1255-2020)
- Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01 (D-1254-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.