Drug recall
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only…
FDA recall event 87038 · Class II · CIPLA
Key facts
| Event ID | 87038 |
|---|---|
| Recall numbers | D-0181-2021, D-0182-2021, D-0183-2021 |
| Recalling firm | CIPLA |
| Product type | Drugs |
| Products | 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…, 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline |
| Initiation date | Dec 17, 2020 |
| Report date | Jan 6, 2021 |
| Termination date | Dec 7, 2022 |
| City | Warren |
| State | NJ |
| Country | United States |
| FEI number | 3014780658 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: