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.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile injectables) where the hazard is a lack of assurance of sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Vitalab Pharmacy, Inc. is recalling 60 vials of Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, and Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL sterile injectables. The recall was initiated after a review of third-party environmental certification documentation indicated that airflow patterns may not be sufficient to support the aseptic production of these injectable drug products.
The recalled products were distributed to patients throughout the United States. Affected lots include T101 03062018@69, 02052018@56, T104 03122018@62, 02072018@95, T105 03122018@63, 02072018@96, and T106 03122018@64, 02072018@97, with expiration dates ranging from 06/04/2018 to 06/10/2018.
Patients who have received these products should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc
- Manufacturer
- Vitalab Pharmacy, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 60
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 (9)
- Lot #:T101 03062018@69
- 02052018@56
- T104 03122018@62
- 02072018@95
- T105 03122018@63
- 02072018@96
- T106 03122018@64
- 02072018@97
- Exp 06/04/2018-06/10/2018
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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