The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0002-2017·Announced 2016-10-12

Methylcobalamin Injection Recalled Due to Sterility Assurance Issues

The Apothecary Shoppe LLC is recalling Methylcobalamin 5000 mcg/mL Injection in Oklahoma because the medication was sterilized with a recalled filter.

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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury if administered.

Plain-English summary

The Apothecary Shoppe LLC is recalling Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials for intramuscular use. The recall affects 419 mL of the medication distributed in Oklahoma. The specific lots involved have codes 071222016@24 with a best use date of 01/08/2017, and 05112016@8 with a best use date of 11/07/2016.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that the medication was sterilized using a filter that was itself subject to a recall. This defect raises concerns about the potential presence of microbial contamination in the injectable product.

Consumers and healthcare providers in Oklahoma who have this product should stop using it and contact The Apothecary Shoppe LLC or their healthcare provider for instructions on return or disposal. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK
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 (2)

  • 071222016@24 BUD 01/08/2017
  • 05112016@8 BUD 11/07/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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