Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceutic
Summary
The FDA issued a Class II for Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx onl by Hetero USA Inc. Reason: CGMP Deviations: Discoloration.
Details
Source
Drug Recall
External ID
D-0530-2023
Action Date
2023-04-19
Status
Ongoing
Category
drug
Product Description
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
Lot/Code Info: Lot #: PAN22542, Exp. Date: 9/2024
Quantity Affected: 2,352 bottles
Reason for Recall
CGMP Deviations: Discoloration
Distribution
Nationwide within the United States
Type: N/A
Recall Initiated: 2023-03-14
Company
Piscataway, 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 63 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Hetero USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hetero USA Inc have FDA actions?
This is the only FDA action we have on record for Hetero USA Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0530-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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