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Recall Observatory FDA recall evidence

Drug 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

D-1074-2015

March 17, 2015

Class II

Product summary

Firm
Fallon Wellness Pharmacy, L.L.C.
Event
Event 70807
Status
Terminated
Classification
Class II
Quantity
56 vials
Official record key
drug-enforcement:D-1074-2015

Official wording

Reason: Lack of assurance of sterility

Code information: 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

Distribution pattern: New York

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility