Avet Pharmaceuticals of East Brunswick, N.J., is recalling 100-count bottles of Tetracycline HCl capsules.
The medication has low out of specification dissolution test results, which results in less tetracycline available in the body to fight infection. This can lead to treatment failures.
The firm has not received any adverse event reports or complaints.
The following products, distributed under the Heritage Pharmaceuticals label, are being recalled:
|Product||NDC Number||Lot No||Expiry Date|
|Tetracycline HCl Capsules 250 mg 100 count||23155-017-01||H190666||JUL 2022|
|Tetracycline HCl Capsules 500 mg 100 count||23155-018-01||G190609||JUN 2022|
|Tetracycline HCl Capsules 500 mg 100 count||23155-018-01||G190610||JUN 2022|
|Tetracycline HCl Capsules 500 mg 100 count||23155-018-01||G190611||JUN 2022|
|Tetracycline HCl Capsules 500 mg 100 count||23155-018-01||L191027||NOV 2022|
|Tetracycline HCl Capsules 500 mg 100 count||23155-018-01||L191028||NOV 2022|
|Tetracycline HCl Capsules 500 mg 100 count||23155-018-01||K190953||OCT 2022|
|Tetracycline HCl Capsules 500 mg 100 count||23155-018-01||K190952||OCT 2022|
The recalled products, used for treatment of infections caused by susceptible strains of the designated organisms, including upper and lower respiratory infections, skin and soft tissues infections, infections caused by Rickettsiae, as adjunctive therapy in severe acne, were distributed to wholesalers and distributors throughout the U.S. from between August 2019 – March 2020.
What to do
Avet is notifying its distributors and customers by a separate notification to distributors and through Qualanex and is arranging for the return of all recalled products.
Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product.
Consumers with questions may contact Qualanex at (888) 424-4341. Monday – Friday, 8:00 am – 5:00 pm, (EST) or by email at firstname.lastname@example.org.