Esomeprazole Magnesium for Delayed-Release Oral recall: Contamination
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
Why was Esomeprazole Magnesium for Delayed-Release Oral recalled?
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: KA00413, KA00414, KA00461, Exp 11/2021
- 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
- Recalling firm
- CIPLA
- Quantity
- 289350 packets
- Distribution
- U.S.A. Nationwide
- Recall date
- January 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)