Recalls / Class II
Class IID-0183-2021
Product
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34
- Brand name
- Esomeprazole Magnesium
- Generic name
- Esomeprazole Magnesium
- Active ingredient
- Esomeprazole Magnesium Dihydrate
- Route
- Oral
- NDCs
- 69097-528, 69097-529
- FDA application
- ANDA211751
- Affected lot / code info
- Lot #: KA00415, KA00416, Exp 11/2021
Why it was recalled
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Recalling firm
- Firm
- CIPLA
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 6,491 packets
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-12-17
- FDA classified
- 2020-12-30
- Posted by FDA
- 2021-01-06
- Terminated
- 2022-12-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0183-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.