Recalls / Class II
Class IID-1075-2015
Product
Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
- Affected lot / code info
- Lot#: a) 02092015@59, Exp 4/10/15; b) 02122015@49, Exp 4/13/15; c) 02132015@44, Exp 4/14/15; d) 02192015@34, Exp 4/20/15
Why it was recalled
Lack of assurance of sterility
Recalling firm
- Firm
- Fallon Wellness Pharmacy, L.L.C.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1057 Troy Schenectady Rd, N/A, Latham, New York 12110-1002
Distribution
- Quantity
- 70 vials
- Distribution pattern
- New York
Timeline
- Recall initiated
- 2015-03-17
- FDA classified
- 2015-05-12
- Posted by FDA
- 2015-05-20
- Terminated
- 2018-06-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1075-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.