The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1316-2015·Announced 2015-08-12

Apothecary Shoppe Recalls S-Methylcobalamin Injection Due to Sterility Concerns

The Apothecary Shoppe LLC is recalling S-Methylcobalamin 5000 mcg/mL Injection in 750 mL containers due to a lack of assurance of sterility.

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. The hazard is a lack of assurance of sterility due to documentation issues, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported illness.

Plain-English summary

The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling S-Methylcobalamin 5000 mcg/mL Injection, Rx Only, in 750 mL containers. The recall is limited to Lot # 05012015@4 with a beyond-use date of 10/28/2015. The product was distributed in Oklahoma.

The recall was initiated due to a lack of assurance of sterility. This issue arose because there was a lack of documentation of proper environmental monitoring during the time the medication was produced.

Consumers and healthcare providers who have this specific lot of S-Methylcobalamin Injection should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
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 (2)

  • Lot #: 05012015@4
  • BUD 10/28/2015

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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