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.
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 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.
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