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Class II · ModerateRecall completed

Esomeprazole Magnesium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: KA00415, KA00416, Exp 11/2021
Where it was soldU.S.A. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 foreign manufacturer
Brand nameESOMEPRAZOLE MAGNESIUM
Generic nameESOMEPRAZOLE MAGNESIUM
Active ingredient(s)ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Distributed by / forCipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059
NDC69097-529-34
Show the full FDA record
Full product labelEsomeprazole 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
Recalling firmCIPLA
DistributionU.S.A. Nationwide
Quantity6,491 packets
Recall initiated2020-12-17
Report date2021-01-06
Recall completed2022-12-07
Recall numberD-0183-2021
ClassificationClass II
FDA statusTerminated
Origin on fileWarren NJ United States

Related

Omeprazole recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.