Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippa
Summary
The FDA issued a Class II for Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: by Teva Pharmaceuticals USA Inc. Reason: Failed Moisture Limits: Water (moisture) content above the approved product specifications..
Details
Source
Drug Recall
External ID
D-0913-2023
Action Date
2023-07-19
Status
Terminated
Category
drug
Product Description
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Lot/Code Info: Lot # 100037220, Exp 10/2024
Quantity Affected: 180 bottles
Reason for Recall
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Distribution
Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-05
Company
Parsippany, 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 59 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 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 (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-0913-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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