Recalls / Class II
Class IID-1074-2015
Product
Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
- Affected lot / code info
- Lot#: a) 02052015@53, Exp 4/6/15; b) 01142015@31, Exp 3/15/15; c) 02022015@6, Exp 4/3/15; d) 01132015@72, Exp 3/14/15; e) 01282015@57, Exp 3/29/15; f) 01302015@50, Exp 3/31/15; g) 01232015@14, Exp 3/24/15
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
- 56 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-1074-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.