Vitalab Pharmacy Recalls Sterile Injectable Drugs Due to Sterility Concerns
Vitalab Pharmacy is recalling specific lots of sterile injectable drugs 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While no specific injuries are reported in the text, the risk of sterility failure in injectable drugs is a significant health hazard.
Plain-English summary
Vitalab Pharmacy, Inc. is recalling specific lots of Papaverine/Phentolamine/Prostaglandin sterile injectable drugs. The recall was initiated after a review of third-party environmental certification documentation indicated that airflow patterns in the production facility may not be sufficient to support the aseptic production of certain injectable drug products.
The recalled product is identified by Lot # 03052018@54. The product was distributed to patients throughout the United States. The primary concern is a lack of assurance of sterility, which poses a risk of contamination for patients receiving these injectable medications.
Patients who have received this product should contact their healthcare provider for guidance on next steps. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
- Manufacturer
- Vitalab Pharmacy, Inc
- Category
- Drug — Injectable
- Hazard
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 #: 03052018@54
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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