FDA Recalls Teva Alprostadil Injection for Failed Impurity Specifications
Teva Pharmaceuticals USA Inc is recalling Alprostadil Injection USP due to out-of-specification results for impurities identified during routine stability testing. This FDA Class III recall affects 3,109 cartons distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or adverse events. Out-of-specification impurities and degradation were discovered during routine stability testing, representing a preventive quality control measure. Class III recalls without reported harm are scored 1 or 2 per the severity rubric.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Alprostadil Injection USP 500 mcg/mL in single-dose vials (Carton NDC 0703-1501-02, Vial NDC 0703-1501-01) due to failed impurity and degradation specifications. The recall affects approximately 3,109 cartons that were distributed nationwide in the United States. The affected lots are Lot #100022404 (expiration 10/2022) and Lot #100023333 (expiration 12/2022).
The recall was initiated following discovery of out-of-specification results for impurities during routine stability testing. The impurity levels failed to meet required specifications, indicating potential quality defects in the affected batches.
Patients and healthcare providers who have the affected product should not use it and should contact Teva Pharmaceuticals USA Inc or their healthcare provider with questions. The product is distributed by prescription only.
The recalled product
- Product
- 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
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- Hazard
- impurity
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #:100022404
- Exp Date 10/2022
- Lot #:100023333
- Exp Dat 12/2022
Distribution
Distributed nationwide across the United States.
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