Apothecary Shoppe Recalls Prostaglandin E1 Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIU-Prostaglandin E1 500 mcg/mL Injection vials in Oklahoma due to lack of documentation for environmental monitoring during production.
What this means for you
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 is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vials. The recall is limited to specific lots distributed in Oklahoma. The affected lot numbers are 05042015@33 with a beyond-use date of 10/31/2015, and 03102015@45, 03112015@14, and 03192015@42 with a beyond-use date of 09/01/2015.
The recall was initiated due to a lack of assurance of sterility. The source text states that proper environmental monitoring documentation was missing during the time the medication was produced. This is classified as an FDA Class II recall.
Consumers and healthcare providers should stop using the affected vials and contact the pharmacy or their healthcare provider for further instructions. The recall is specific to the listed lot numbers and distribution area.
The recalled product
- Product
- SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Compounded Injection
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 (6)
- Lot #: 05042015@33
- BUD 10/31/2015
- 03102015@45
- 03112015@14
- 03192015@42
- BUD 09/01/2015
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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