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
Reported: January 6, 2021 Initiated: December 17, 2020 #D-0181-2021
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
Details
- Recalling Firm
- CIPLA
- Units Affected
- 284,610 packets
- Distribution
- U.S.A. Nationwide
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by CIPLA. Units affected: 284,610 packets.
Why was this product recalled? ▼
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 6, 2021. Severity: Moderate. Recall number: D-0181-2021.
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