Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc.,
Summary
The FDA issued a Class I for Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in In by Teva Pharmaceuticals USA Inc. Reason: Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing..
Details
Source
Drug Recall
External ID
D-0992-2022
Action Date
2022-06-08
Status
Terminated
Category
drug
Product Description
Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
Lot/Code Info: Lot # GD01090, Exp 05/2022
Quantity Affected: 4224 cartons
Reason for Recall
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-11
Company
Parsippany, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 105 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Teva Pharmaceuticals 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 Teva Pharmaceuticals USA Inc have FDA actions?
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0992-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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