D-0181-2021 Class II Terminated
FDA drug recall D-0181-2021 was initiated by CIPLA on Dec 17, 2020 and is designated Class II. Reason for recall: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline The recall status is terminated (terminated Dec 7, 2022). Affected quantity: 284,610 packets.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 6, 2021
- Initiation Date
- Dec 17, 2020
- Termination Date
- Dec 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 284,610 packets
Product Description
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, 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 69097-527-34
Reason for Recall
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: KA00411, KA00412, KA00460, Exp 11/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0181-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026