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The company is recalling Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles because of failed dissolution specifications.
Avet Pharmaceuticals (East Brunswick, New Jersey) is voluntarily recalling Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles because of low out-of-specification dissolution test results. The recalled product was distributed under the Heritage Pharmaceuticals label nationwide in the United States between August 2019 and March 2020.
Tetracycline HCl Capsules USP, 250 mg and 500 mg are used to treat infections, including upper and lower respiratory infections, and according to the company, low dissolution may result in less drug in the patient, which could cause treatment failure. “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,” the company said in a press release.
The company has not received adverse event reports or complaints related to the recalled product. Adverse events may be reported to FDA through its MedWatch program.