Drug recall D-0289-2019
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
Reason for recall
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).
Lots and codes
Lot#: OWSA18002-A, Exp 7/2020
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 4464 bottles
- Distribution
- U.S.A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 30, 2018
- Terminated
- February 1, 2022
Related products
- Amlodipine and Olmesartan Medoxomil – drug information
- NDC 65862-856 Amlodipine and Olmesartan Medoxomil · Amlodipine Besylate 10 mg/1; Olmesartan Medoxomil 20 mg/1 · Aurobindo Pharma Limited
- NDC 65862-855 Amlodipine and Olmesartan Medoxomil · Amlodipine Besylate 5 mg/1; Olmesartan Medoxomil 40 mg/1 · Aurobindo Pharma Limited
- NDC 65862-854 Amlodipine and Olmesartan Medoxomil · Amlodipine Besylate 5 mg/1; Olmesartan Medoxomil 20 mg/1 · Aurobindo Pharma Limited
- NDC 65862-857 Amlodipine and Olmesartan Medoxomil · Amlodipine Besylate 10 mg/1; Olmesartan Medoxomil 40 mg/1 · Aurobindo Pharma Limited