Apothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns
The Apothecary Shoppe is recalling specific lots of SIU-Papav/Phentol 30/1 mg/mL Injection due to a lack of documentation for environmental monitoring during production.
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. According to the rubric, an FDA Class II recall with potential for adverse health consequences (such as sterility issues in an injectable medication) corresponds to a severity score of 4 (Severe).
Plain-English summary
The Apothecary Shoppe LLC is recalling 70 mL of SIU-Papav/Phentol 30/1 mg/mL Injection, a prescription-only medication available in 5 mL vials. The recall affects specific lots distributed in Oklahoma, identified by lot numbers 03102015@30 (Best Use Date 7/8/2015) and 04162015@30 (Best Use Date 10/13/2015).
The recall was initiated due to a lack of assurance of sterility. The company reported a lack of documentation confirming proper environmental monitoring during the time the medication was produced. This documentation gap raises concerns about the sterility of the product.
Patients who have received this medication should contact their healthcare provider for guidance. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Injectable Medication
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 (4)
- Lot #s: 03102015@30
- BUD 7/8/2015
- 04162015@30
- BUD 10/13/2015
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 28 recalled by The Apothecary Shoppe LLC 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.
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