Vitalab Alprostadil Injectable Recalled for Sterility Assurance Concerns
Vitalab Pharmacy is recalling Alprostadil 20 mcg/mL injectable vials because airflow patterns may not support aseptic production, raising sterility concerns.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving potential sterility issues in injectable drugs are categorized as Severe (Score 4) due to the risk of infection, even without reported hospitalizations in the source text.
Plain-English summary
Vitalab Pharmacy, Inc. is recalling Alprostadil 20 mcg/mL, sterile injectable, 2 vials. The recall involves Lot # 02122018@77 with an expiration date of 05/13/2018. The product was distributed to patients throughout the United States.
The recall was initiated due to a lack of assurance of sterility. Upon review of recent third-party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Patients who have received this product should contact their healthcare provider for further instructions. The recalled product should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
- Manufacturer
- Vitalab Pharmacy, Inc
- Category
- Drug — Injectable
- Affected units
- 2
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 #: 02122018@77
- Exp 05/13/2018
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Vitalab Pharmacy, Inc 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.
See all 6 products in this recall →Related recalls
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