The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1075-2015·Announced 2015-05-20

Fallon Wellness Pharmacy Recalls Hydroxocobalamin Injections Due to Sterility Concerns

Fallon Wellness Pharmacy is recalling 70 vials of Hydroxocobalamin injections in New York due to a lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (injection) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Fallon Wellness Pharmacy, L.L.C. is recalling 70 vials of Hydroxocobalamin injections in three concentrations: 1000mcg/mL, 5mg/0.5mL, and 5000mcg/0.2mL. The recall is being conducted because of a lack of assurance of sterility.

The affected products were distributed in New York. The specific lot numbers involved are 02092015@59 (Exp 4/10/15), 02122015@49 (Exp 4/13/15), 02132015@44 (Exp 4/14/15), and 02192015@34 (Exp 4/20/15).

Consumers and healthcare providers should stop using these products and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Manufacturer
Fallon Wellness Pharmacy, L.L.C.
Category
Drug — Injection
Hazard
Affected units
70

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 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

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 10 recalled by Fallon Wellness Pharmacy, L.L.C. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Related recalls

Same manufacturer · Fallon Wellness Pharmacy, L.L.C.

See all →

Same hazard · sterility

See all →

Similar recalls