Drug recall D-0182-2021
Product
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, 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 69097-528-34
Reason for recall
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Lots and codes
Lot #: KA00413, KA00414, KA00461, Exp 11/2021
Recall details
- Recalling firm
- CIPLA, Warren, NJ
- Quantity
- 289350 packets
- Distribution
- U.S.A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 17, 2020
- Terminated
- December 7, 2022
Related products
- Esomeprazole Magnesium – drug information
- NDC 69097-528 Esomeprazole magnesium · Esomeprazole Magnesium Dihydrate 20 mg/1 · Cipla USA Inc.
- NDC 69097-529 Esomeprazole magnesium · Esomeprazole Magnesium Dihydrate 40 mg/1 · Cipla USA Inc.