The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1071-2015·Announced 2015-05-20

Fallon Wellness Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

Fallon Wellness Pharmacy is recalling 6 vials of Papaverine/phentolamine/prostaglandin injection 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 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile injections.

Plain-English summary

Fallon Wellness Pharmacy, L.L.C. is recalling 6 vials of Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection. The product was distributed in New York. The specific lot number is 12012014@65, with an expiration date of 4/12/15.

The recall was initiated because of a lack of assurance of sterility. This means the manufacturer cannot guarantee that the medication is free from microbial contamination.

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

The recalled product

Product
Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Manufacturer
Fallon Wellness Pharmacy, L.L.C.
Category
Drug — Injection
Hazard
Affected units
6

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#: 12012014@65
  • 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 →

Related recalls

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

See all →

Same hazard · sterility

See all →

Similar recalls