Westlab Pharmacy Recalls Alprostadil Injectable Vials Due to Incorrect Formulation
Westlab Pharmacy is recalling 80 vials of Alprostadil 500 mcg/mL Injectable due to an incorrect product formulation. The recall covers nationwide distribution.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the source text does not report any specific injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Westlab Pharmacy, Inc. is recalling 80 syringes of Alprostadil 500 mcg/mL Injectable, Vials (NDC 10002-7335-00). The recall is being conducted because the product was found to have an incorrect product formulation.
The affected product is identified by Lot 03192018@42, with a discard date of 9/15/2018. The recall covers nationwide distribution.
Consumers and healthcare providers should stop using the recalled product and contact Westlab Pharmacy or their healthcare provider for further instructions.
The recalled product
- Product
- Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
- Manufacturer
- Westlab Pharmacy, Inc. dba Westlab Pharmacy
- Category
- Drug — Injectable
- Hazard
- Affected units
- 80
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 (1)
- Lot: 03192018@42 Discard after 9/15/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Westlab Pharmacy, Inc. dba Westlab Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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