The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1289-2015·Announced 2015-08-12

Apothecary Shoppe Recalls S-Methylcobalamin Injection Due to Sterility Concerns

The Apothecary Shoppe is recalling S-Methylcobalamin 1000 mcg/mL 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 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 issue) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

The Apothecary Shoppe LLC is recalling S-Methylcobalamin 1000 mcg/mL (PF) Injection, a prescription-only medication available in 10 mL vials. The recall involves 64 mL of product distributed in Oklahoma. Specific lot numbers affected are 03132015@28, 04082015@46, and 04222015@5.

The recall was initiated due to a lack of assurance of sterility. This issue arose because proper documentation of environmental monitoring during the time the medication was produced was not available. The U.S. Food and Drug Administration has classified this recall as Class II.

Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40
Manufacturer
The Apothecary Shoppe LLC
Category
Drug — 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 (6)

  • Lot #s: 03132015@28
  • BUD 9/9/2015
  • 04082015@46
  • BUD 10/5/2015
  • 04222015@5
  • BUD 10/19/2015

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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