Esomeprazole Magnesium Delayed-Release Capsules recall: Superpotent
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.
Why was Esomeprazole Magnesium Delayed-Release Capsules recalled?
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot AC14299, Exp 12/2022
- Product
- 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.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 5712 bottles
- Distribution
- Nationwide in the USA
- Recall date
- October 5, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)