FDA recall D-1254-2020

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.

Distribution

Distributed Nationwide in the US

Key facts

Status

Terminated

Initiation date

2020-03-23

Report date

2020-04-15

Termination date

2022-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1254-2020