Drug Safety Alerts

Ranitidine Hydrochloride Capsules Consumer-Level Recall

10/25/2019

On October 23, 2019, Mylan issued a consumer-level recall of Alprazolam 0.5 mg tablets NDC # 00378-4003-05. This recall was issued due to the potential presence of foreign substance. Clinical impact from the foreign material, if present, is expected to be rare, but the remote risk of infection to a patient cannot be ruled out.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

This recall affects lot number 8082708 exp. 09/20. The affected lot was distributed in the U.S. between July 2019 and August 2019.

CVS Caremark Response:

Please note: This product is carried by the CVS Caremark Mail Service Pharmacies.

Because of this action, CVS Caremark is sending letters to members who received this product through CVS Caremark Mail Service Pharmacy and their physicians.

For more information about this recall, please contact Mylan Customer Relations at 1‑800.796.9526, Monday through Friday, 8:00 a.m. to 5:00 p.m. (ET) or visit https://newsroom.mylan.com.

You may also call the United States Food and Drug Administration (FDA) at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.