The Recall Desk
SevereFDA (Drugs)·D-1003-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Myers' Cocktail Vials for Sterility Concerns

Well Care Compounding Pharmacy is recalling Myers' Cocktail vials due to FDA inspection findings of GMP violations that may affect sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the agency classification is Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential sterility issues in injectable products.

Plain-English summary

Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Myers' Cocktail, packaged in 37 mL vials. The product is prescription-only and was distributed in Nevada. The recall involves multiple lots with expiration dates ranging from January 2016 to May 2016.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The agency has classified this as a Class II recall.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.

The recalled product

Product
MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer
Well Care Compounding Pharmacy
Category
Drug — Injectable Compounded Medication
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 (20)

  • Lot #: 01112016:29@20
  • Exp. 01/19/2016
  • Lot #:01202016: 85@9
  • Exp. 01/27/2016
  • Lot #: 01222016: 56@17
  • Exp. 01/29/2016
  • Lot #: 01222016:36@49
  • Exp.02/02/2016
  • Lot #: 01262016:72@12
  • Lot #: 01262016: 56@58
  • Exp.02/03/2016
  • Lot #: 02052016:89@26
  • Exp.03/02/2016
  • Lot #: 02112016:55@39
  • Exp.03/03/2016
  • Lot #: 02102016: 95@17
  • Exp. 03/08/2016
  • Lot #: 02222016:39@46
  • Exp. 03/15/2016
  • Lot #: 04222016:40@48

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 →

Related recalls

Same manufacturer · Well Care Compounding Pharmacy

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Same hazard · sterility

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