Class II
Terminated
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
- Company
- Cipla
- Recall Initiated
- December 17, 2020
- Posted
- January 6, 2021
- Recall Number
- D-0183-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6,491 packets
- Firm Location
- Warren, NJ, United States
Reason for Recall
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Distribution
U.S.A. Nationwide
Lot / Code Info
Lot #: KA00415, KA00416, Exp 11/2021
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