The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0986-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Sterility-Compromised Glutathione Vials

Well Care Compounding Pharmacy is recalling 869 vials of Glutathione 100mg/mL due to FDA-identified GMP violations that may compromise 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 involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.

Plain-English summary

Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Glutathione 100mg/mL packaged in 10 mL vials. The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.

The affected product is distributed in Nevada. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between February 2016 and July 2016. The source text does not report any illnesses or injuries associated with the use of these products.

Consumers who have purchased these specific vials should stop using them and contact the recalling firm or their healthcare provider for instructions on return or disposal.

The recalled product

Product
GLUTATHIONE 100MG/ML, packaged in 10 mL vials, 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 (15)

  • Lot #: 02222016:97@38
  • Exp.05/24/2016
  • Lot #: 03032016:27@26
  • Exp. 06/26/2016
  • Lot #: 4272016:60@37
  • Exp. 07/26/2016
  • Lot #: 01132016:18@44
  • Exp. 02/03/2016
  • Lot #: 01132016:74 @17
  • Exp. 03/04/2016
  • Lot #: 01132016:90@9
  • Lot #: 02222016:34@23
  • Exp. 04/03/2016
  • Lot #: 04282016:79@45
  • Exp. 06/27/2016

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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