Recall: D-0392-2021

Class III - Minor Violations

Class IIIClassification

2021-04-29Initiated

TerminatedStatus

Ascend Laboratories LLCFirm

Product

Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.

Reason

Presence of Foreign Tablet/Capsule

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.