Apothecary Shoppe Recalls SIU-Phent Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIU-Phent .4 mg/PGE1 20 mcg/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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While specific injury reports are not detailed in the text, the lack of sterility assurance in an injectable drug presents a significant risk of harm, aligning with the Severe criteria for high-risk products.
Plain-English summary
The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial. The recall affects 378 mL of the medication distributed in Oklahoma. Specific lots involved include 04282015@9, 04172015@15, and 04022015@10.
The recall was initiated due to a lack of assurance of sterility. This issue arose because there was a lack of documentation of proper environmental monitoring during the time the medication was produced. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Compounded Injectable
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 #s: 04282015@9
- BUD 10/25/2015
- 04172015@15
- BUD 10/14/2015
- 04022015@10
- BUD 9/1/2015
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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