The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0996-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Methyl B12 Due to Sterility Concerns

Well Care Compounding Pharmacy is recalling Methyl B12 vials because FDA inspections found violations that may affect 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 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 the hazard involves a risk of harm (lack of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada. A total of 869 units are affected by this recall.

The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The specific lot number is 03222016:11@22, with an expiration date of 09/20/2016.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions or a replacement.

The recalled product

Product
M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer
Well Care Compounding Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
869

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 #: 03222016:11@22
  • Exp. 09/20/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Well Care Compounding Pharmacy 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 51 products in this recall →

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