Recalls / Class III
Class IIID-1134-2017
Product
AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10
- Brand name
- Amlodipine Besylate
- Generic name
- Amlodipine Besylate
- Active ingredient
- Amlodipine Besylate
- Route
- Oral
- NDCs
- 67877-197, 67877-198, 67877-199
- FDA application
- ANDA078925
- Affected lot / code info
- Lot #: 6142626, Exp 09/19
Why it was recalled
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Recalling firm
- Firm
- Ascend Laboratories LLC
- Manufacturer
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 180 Summit Ave Ste 200, N/A, Montvale, New Jersey 07645-1722
Distribution
- Quantity
- 1212 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2017-05-05
- FDA classified
- 2017-09-11
- Posted by FDA
- 2017-09-20
- Terminated
- 2018-04-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1134-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.