East Brunswick,
New Jersey,
United States
Company name: Avet Pharmaceuticals Labs Inc.
Brand name: Heritage
Product recalled: Tetracycline HCl Capsules, 250mg and 500mg
Reason of the recall: Due to low out of specification dissolution results
FDA Recall date: April 16, 2020
Recall details: Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.
- Tetracycline HCl Capsules 250 mg 100 count. NDC number: 23155-017-01. Lot No: H190666. Expiry Date: JUL 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: G190609. Expiry Date: JUN 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: G190610. Expiry Date: JUN 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: G190611. Expiry Date: JUN 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: L191027. Expiry Date: NOV 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: L191028. Expiry Date: NOV 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: K190953. Expiry Date: OCT 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: K190952. Expiry Date: OCT 2022
These drug products are manufactured by Avet Pharmaceuticals Labs Inc. and distributed under the Heritage Pharmaceuticals Inc. label. The voluntary recall is being initiated due to low out of specification dissolution test results.
Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event.
The recalled Tetracycline HCl Capsules 250 mg and 500 mg lots were distributed to wholesalers and distributors Nationwide in United States between August 2019 and March 2020.
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. Pharmacies and healthcare facilities that have the drug product subject to this recall should immediately stop dispensing this drug product.
Check the full recall details on
www.fda.gov
Source: FDA
