Avet Pharmaceuticals Inc. issued a voluntary recall for 8 lots of tetracycline HCl capsules USP in 100-count bottles of 250-mg and 500-mg dosages, due to test results showing low dissolution rates.
Low dissolution rates mean that the pill does not dissolve properly, which fails to release enough of the medication into a patient’s body. This can lead to treatment failure, according to the recall notice.
If the tetracycline is being used to treat a serious condition like pneumonia, there is a potential risk of rapid progression of the infection and death, according to the recall notice — especially for older adults and patients with vulnerable immune systems.
No adverse events related to low dissolution have been reported.
The recalled tetracycline was distributed nationwide under the Heritage Pharmaceuticals Inc. label from August 2019 to March 2020.
Tetracycline is used to treat infections, including upper and lower respiratory infections, skin or soft-tissue infections, infections caused by Rickettsiae, and severe acne.
Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug.
Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341. Monday – Friday, 8:00 am – 5:00 pm, EST and or email@example.com.
Source: Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications