The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0987-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Sterility-Compromised Glutathione Vials

Well Care Compounding Pharmacy is recalling 869 vials of Glutathione 200mg/mL due to GMP 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 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 the hazard involves a lack of assurance of sterility in a medical product, which carries a risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Glutathione 200mg/mL packaged in 5mL 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. The hazard is a lack of assurance of sterility, which poses a risk of infection or other adverse health effects if the product is administered to patients.

Consumers and healthcare providers should stop using the affected product immediately. Patients who have received the product should contact their healthcare provider for evaluation. The recalling firm is responsible for managing the recall and providing further instructions to affected parties.

The recalled product

Product
GLUTATHIONE 200MG/ML, packaged in 5mL 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 (8)

  • Lot #: 02232016: 64@43
  • Exp. 05/24/2016
  • Lot #: 03142016: 70@16
  • Exp. 06/14/2016
  • Lot #: 04182016:17@15
  • Exp.07/17/2016
  • Lot #: 04182016:64@12
  • Exp. 07/18/2016.

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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