FDAFDA · Food and drugs·Recall number D-0181-2021
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
Published January 6, 2021 · Recall initiated: December 17, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- CIPLA
- Distributor
- U.S.A. Nationwide
- Lot
- Lot #: KA00411, KA00412, KA00460, Exp 11/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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