Recalls / Class II
Class IID-1119-2015
Product
Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
- Affected lot / code info
- Lot 04202015:49@1, Expiry date: 5/20/2015; Lot 04272015:06@6, Expiry date: 6/2/2015; Lot 04282015:16@13, Expiry date: 6/12/2015; Lot 05062015:56@3, Expiry date: 5/24/2015;
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
- 259/0.05 mL Syringes
- 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-1119-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.