The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1294-2015·Announced 2015-08-12

Apothecary Shoppe Recalls Papaverine Injection Due to Sterility Documentation Gaps

The Apothecary Shoppe LLC is recalling SIU-Papaverine 30 mg/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 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a documentation gap regarding sterility assurance, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

The Apothecary Shoppe LLC is recalling SIU-Papaverine 30 mg/mL Injection, a prescription-only medication packaged in 5 mL vials. The recall involves specific lots identified by the codes 04152015@6 and 03102015@41. The product was distributed in Oklahoma.

The recall was initiated due to a lack of assurance of sterility. Specifically, the company failed to document proper environmental monitoring during the time the medication was produced. This documentation gap prevents verification that the product met sterility standards.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or the recalling firm, The Apothecary Shoppe LLC, for disposal or credit.

The recalled product

Product
SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10
Manufacturer
The Apothecary Shoppe LLC
Category
Drug — 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 #: 04152015@6
  • BUD 10/12/2015
  • 03102015@41
  • BUD 07/08/2015

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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