Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules pe
Summary
The FDA issued a Class II for Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole ma by Dr. Reddy's Laboratories, Inc.. Reason: CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle..
Details
Source
Drug Recall
External ID
D-0026-2022
Action Date
2021-10-27
Status
Terminated
Category
drug
Product Description
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
Lot/Code Info: BT001594C
Quantity Affected: 8,976 bottles
Reason for Recall
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-05
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 32 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dr. Reddy's Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr. Reddy's Laboratories, Inc. have FDA actions?
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0026-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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