Esomeprazole Magnesium For Suspension
FDA Recall NDC 69097-528
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Esomeprazole Magnesium (NDC 69097-528). A significant event, classified as Class II, was initiated on Dec 17, 2020 by Cipla Usa Inc.. The reported reason for this action was: "Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Dec 17, 2020
Jan 06, 2021
6,491 packets
Recall Profile & Regulatory Data
Event ID
87038
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CIPLA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Dec 07, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# : KA00415, KA00416, Exp 11/2021
Affected Packages Involved in this Recall
69097-528-34Product
69097-529-34Product
Class II Terminated
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Dec 17, 2020
Jan 06, 2021
289350 packets
Recall Profile & Regulatory Data
Event ID
87038
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CIPLA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Dec 07, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# : KA00413, KA00414, KA00461, Exp 11/2021
Affected Packages Involved in this Recall
69097-528-34Product
69097-529-34Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
