The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1299-2015·Announced 2015-08-12

Apothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns

The Apothecary Shoppe is recalling specific vials of Papaverine and Phentolamine Injection because documentation for environmental monitoring during production was missing.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a documentation issue regarding environmental monitoring rather than a confirmed contamination or reported injury, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

The Apothecary Shoppe LLC is recalling SIU-Papav/Phentol 30/.5 mg/mL Injection, a prescription-only medication available in 3 mL vials. The recall affects Lot # 04082015@37, which had a beyond-use date of October 5, 2015. The product was distributed in Oklahoma.

The recall was initiated due to a lack of assurance of sterility. The company identified that proper documentation of environmental monitoring was missing during the time the medication was produced. This documentation gap prevents verification that the sterile conditions required for the product were maintained.

Patients who have received this specific medication should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01
Manufacturer
The Apothecary Shoppe LLC
Category
Drug — Compounded Injection
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 (2)

  • Lot #: 04082015@37
  • BUD 10/05/2015

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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