Agency classClass IIOur severity:Severe FDA (Drugs)·D-1297-2015·Announced 2015-08-12

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: sterility
infection

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.

See all 28 products in this recall →

Same manufacturer · The Apothecary Shoppe LLC

See all →

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Same hazard · sterility