Why it was recalled
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
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
Lot numbers, UPCs & expiration codes
Lot #: KA00413, KA00414, KA00461, Exp 11/2021
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0182-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 17, 2020
- FDA report date
- Jan 6, 2021
- Quantity
- 289350 packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CIPLA
Original FDA data
Every field from FDA enforcement report D-0182-2021, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87038
- Address
- 10 Independence Blvd
- Code information
- Lot #: KA00413, KA00414, KA00461, Exp 11/2021
- Postal code
- 07059-2730
- Report date
- Jan 6, 2021
- Product type
- Drugs
- Recall number
- D-0182-2021
- Classification
- Class II
- Recalling firm
- CIPLA
- Product quantity
- 289350 packets
- Termination date
- Dec 7, 2022
- Reason for recall
- Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Dec 17, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 30, 2020