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| The United States: Avet Pharmaceuticals Inc. issues voluntary nationwide recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg due to failed dissolution specifications (English only) |
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The US Food and Drug Administration (FDA) announces that Avet Pharmaceuticals Inc., 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 to the consumer/user level:
- Tetracycline HCl Capsules 250 mg (lot number: H190666)
- Tetracycline HCl Capsules 500 mg (lot number: G190609, G190610, G190611, L191027, L191028, K190953, K190952)
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avet-pharmaceuticals-inc-issues-voluntary-nationwide-recall-tetracycline-hcl-capsules-usp-250-mg-and
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Apr 17, 2020
Issued at HKT 16:00
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