The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1296-2015·Announced 2015-08-12

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.

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 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
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: 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.

See all 28 products in this recall →

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