The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0998-2016·Announced 2016-06-15

FDA Recalls Well Care Compounding Pharmacy M.l.C./B5/B6 Injection for Sterility Concerns

Well Care Compounding Pharmacy is recalling M.l.C./B5/B6 injection vials due to FDA inspection findings of GMP violations that may impact 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 involves a risk-of-harm product (sterility issues in an injectable) 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./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada. The recall involves specific lots with expiration dates in March and May 2016.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, creating a lack of assurance of sterility.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer
Well Care Compounding Pharmacy
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 #: 01272016:00@24
  • Exp.03/28/2016
  • Lot #: 03292016: 96@35
  • Exp. 05/24/2016

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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