Recalls / Class II
Class IID-1121-2015
Product
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
- Affected lot / code info
- Lot 04102015:70@12; expiry date 5/28/2015.
Why it was recalled
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recalling firm
- Firm
- Montana Compounding Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 N Higgins Ave, N/A, Missoula, Montana 59802-4437
Distribution
- Quantity
- 20/4 mL vials
- Distribution pattern
- MT and ND
Timeline
- Recall initiated
- 2015-05-15
- FDA classified
- 2015-06-09
- Posted by FDA
- 2015-06-17
- Terminated
- 2016-12-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1121-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.