Recalls / Class III
Class IIID-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
- Brand name
- Amlodipine And Olmesartan Medoxomil
- Generic name
- Amlodipine And Olmesartan Medoxomil
- Active ingredients
- Amlodipine Besylate, Olmesartan Medoxomil
- Route
- Oral
- NDCs
- 65862-854, 65862-855, 65862-856, 65862-857
- FDA application
- ANDA206906
- Affected lot / code info
- Lot#: OWSA18002-A, Exp 7/2020
Why it was recalled
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).
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 4464 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2018-11-30
- FDA classified
- 2018-12-06
- Posted by FDA
- 2018-12-12
- Terminated
- 2022-02-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0289-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.