FDAFDA · Food and drugs·Recall number D-0004-2023
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
Published October 5, 2022 · Recall initiated: June 21, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide in the USA
- UPC
- 0363304734300
- Lot
- Lot AC14299, Exp 12/2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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