Drug 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
D-0183-2021
Product summary
- Firm
- CIPLA
- Event
- Event 87038
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,491 packets
- Official record key
drug-enforcement:D-0183-2021
Official wording
Reason: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Code information: Lot #: KA00415, KA00416, Exp 11/2021
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline