Teva Recalls Alprostadil Injection Due to Impurity Testing Failures
Teva Pharmaceuticals is recalling Alprostadil Injection vials because routine stability testing revealed out-of-specification impurities.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the recall as FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential significant health risks or structural defects, though no specific hospitalizations are reported in this text.
Plain-English summary
Teva Pharmaceuticals USA is recalling Alprostadil Injection USP 500 micrograms/mL, 1 mL single-use vials. The recall involves 1,362 vials from Lot # 31323147B with an expiration date of 01/2019. The product is prescription-only and was distributed throughout the United States, including Hawaii and Puerto Rico.
The recall was initiated because routine stability testing resulted in out-of-specification results for impurities. This indicates that the product failed to meet established impurities and degradation specifications.
Patients and healthcare providers should stop using the affected vials and contact their healthcare provider for guidance on alternative treatments. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injection
- Hazard
- Affected units
- 1,362
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 (2)
- Lot # 31323147B
- exp. date 01/2019
Distribution
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