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Dissolution problem prompts recall of tetracycline HCl capsules :

April 17, 2020

Eight lots of tetracycline HCl capsules USP in 250 mg and 500 mg 100-count bottles have been voluntarily recalled by Avet Pharmaceuticals Inc., due to low out-of-specification dissolution test results.

Low dissolution results in less tetracycline available in the body to fight infection and can lead to treatment failure, according to the volunteer recall announcement from the company. No adverse events related to low dissolution results have been reported.

The capsules were distributed by Avet Pharmaceuticals Inc. under the Heritage Pharmaceuticals Inc. label to wholesalers and distributors nationwide between August and March.

Recalled are tetracycline HCl 500-mg capsules in 100-count containers with lot numbers G190609, G190610 and G190611 with June 2022 expiration date; lot numbers L191027 and L191028 with November 2022 expiration date; and lot numbers K190953 and K190952 with October 2022 expiration date. One lot of 250-mg tetracycline HCl capsules in 100-count containers (No. H190666) with July 2022 expiration date also is recalled.       

Patients are being instructed to contact their physician for guidance and potential change of treatment before they stop taking the product. Avet also is instructing patients to contact their physician if they have experienced problems related to the product.

Report adverse events to the Food and Drug Administration’s MedWatch Adverse Event Reporting program. Read the announcement here.

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