Recalls / Class II
Class IID-0987-2016
Product
GLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Affected lot / code info
- 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.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recalling firm
- Firm
- Well Care Compounding Pharmacy
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3430 E Tropicana Ave Ste 9, N/A, Las Vegas, Nevada 89121-7345
Distribution
- Quantity
- 869 Units (Total All Products)
- Distribution pattern
- NV
Timeline
- Recall initiated
- 2016-05-17
- FDA classified
- 2016-06-09
- Posted by FDA
- 2016-06-15
- Terminated
- 2017-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0987-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.