The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1073-2015·Announced 2015-05-20

Fallon Wellness Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

Fallon Wellness Pharmacy is recalling 8 vials of Papaverine/phentolamine/prostaglandin injection in New York due to 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe), particularly given the risk of infection associated with a lack of sterility assurance in an injectable medication.

Plain-English summary

Fallon Wellness Pharmacy, L.L.C. is recalling 8 vials of Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection. The recall is being conducted due to a lack of assurance of sterility. The affected product is identified by Lot number 12302014@9 and has an expiration date of 4/12/15.

The recall is limited to the state of New York. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Manufacturer
Fallon Wellness Pharmacy, L.L.C.
Category
Drug — Injectable
Hazard
Affected units
8

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 (2)

  • Lot#: 12302014@9
  • Exp 4/12/15

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 →

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