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.
What this means for you
Illness, injury, or structural failure has been reported. 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
Same manufacturer · Vitalab Pharmacy, Inc
See all →- SevereVitalab Pharmacy Recalls Sterile Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-05-16
- HighVitalab Pharmacy Recalls Sterile Injectable Drugs Due to Sterility Concerns
FDA (Drugs) · 2018-05-16
- SevereVitalab Methylcobalamin Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2018-05-16
- SevereVitalab Pharmacy Recalls Sterile Injectable Drugs Due to Sterility Concerns
FDA (Drugs) · 2018-05-16
- SevereVitalab Alprostadil Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2018-05-16
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29