Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distr
Summary
The FDA issued a Class III for Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, by Teva Pharmaceuticals USA Inc. Reason: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing.
Details
Source
Drug Recall
External ID
D-0988-2022
Action Date
2022-06-15
Status
Terminated
Category
drug
Product Description
Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
Lot/Code Info: Lot #:100022404, Exp Date 10/2022; Lot #:100023333, Exp Dat 12/2022
Quantity Affected: 3109 cartons
Reason for Recall
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Distribution
Product was distributed nationwide in the US Market
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-18
Company
Parsippany, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 180 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0988-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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