US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 7, 2023 (4 years ago)

Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection.

What was recalled

Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA.

Recalling firm
Accord Healthcare, Inc.
NDC code
16729-284-15
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0404-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Rosuvastatin recalls

See all