Drug product
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
D-0289-2019
Product summary
- Event
- Event 81703
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4464 bottles
- Official record key
drug-enforcement:D-0289-2019
Official wording
Reason: Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Code information: Lot#: OWSA18002-A, Exp 7/2020
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).