Reported Jan 6, 2021 · Terminated
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured…
Cipla
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CIPLA · 10 Independence Blvd · Warren, NJ · 07059-2730
Is this the product you have?
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only
- Manufactured byCipla Ltd., Kurkumbh, India
- Manufactured for
Cipla USAInc. 10 Independence BoulevardSuite 300 WarrenNJ 07059NDC 69097-528-34
- Lot codes and dates
Lot #: KA00413KA00414KA00461Exp 11/2021
- Amount recalled
- 289350 packets
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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