The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1301-2015·Announced 2015-08-12

Apothecary Shoppe Recalls Prostaglandin E1 Injection Due to Sterility Concerns

The Apothecary Shoppe LLC is recalling SIU-Prostaglandin E1 20 mcg/mL Injection due to a lack of documentation ensuring proper 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 3/5 (High).

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 failure) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

The Apothecary Shoppe LLC is recalling SIU-Prostaglandin E1 20 mcg/mL Injection, a prescription-only medication available in 10 mL vials. The recall involves 163 mL of the product distributed in Oklahoma. Specific lot numbers affected are 04172015@33 with a beyond-use date of 10/14/2015, and 04292015@10 with a beyond-use date of 10/26/2015.

The recall was initiated due to a lack of assurance of sterility. This issue arose because there was a lack of documentation confirming proper environmental monitoring during the time the medication was produced. The FDA has classified this recall as Class II.

Consumers and healthcare providers in Oklahoma who have this specific medication should stop using it and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product
SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01
Manufacturer
The Apothecary Shoppe LLC
Category
Drug — Compounded Injectable
Hazard

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: 04172015@33
  • BUD 10/14/2015
  • 04292015@10
  • BUD 10/26/2015

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 →

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