GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx o
Summary
The FDA issued a Class II for GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each wit by American Health Packaging. Reason: Failed Dissolution Specifications: results were above specification..
Details
Source
Drug Recall
External ID
D-0020-2022
Action Date
2021-10-27
Status
Terminated
Category
drug
Product Description
GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)
Lot/Code Info: Lot #: 194141, Exp. Date 03/31/2022
Quantity Affected: 2,266 cartons
Reason for Recall
Failed Dissolution Specifications: results were above specification.
Distribution
Nationwide within the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-17
Company
Columbus, OH
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.
American Health Packaging has 7 FDA actions in our database, including 7 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 (American Health Packaging) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Health Packaging have FDA actions?
American Health Packaging has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0020-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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