Vitalab Pharmacy Recalls Sterile Injectable Drug Due to Sterility Concerns
Vitalab Pharmacy is recalling 22 vials of a sterile injectable drug 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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Vitalab Pharmacy, Inc. is recalling 22 vials of Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable. 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. This raises a lack of assurance regarding the sterility of the affected units.
The recalled product was distributed to patients throughout the United States. The specific lot numbers involved are 03092018@52 and 02122018@76, with expiration dates ranging from 05/13/2018 to 06/07/2018. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients who have received this product should stop using it and contact their healthcare provider or Vitalab Pharmacy for further instructions. The recall is based on the potential for the product to not be sterile, which is a critical requirement for injectable medications.
The recalled product
- Product
- Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
- Manufacturer
- Vitalab Pharmacy, Inc
- Category
- Drug — Injectable
- Affected units
- 22
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 (3)
- Lot #: 03092018@52
- 02122018@76
- Exp 05/13/2018-06/07/2018
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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