The Recall Desk
SevereFDA (Drugs)·D-1069-2015·Announced 2015-05-20

Fallon Wellness Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

Fallon Wellness Pharmacy is recalling specific lots of Papaverine/phentolamine/prostaglandin injection in New York due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the provided text, the agency classification of Class II for a sterile injection product aligns with the Severe criteria for significant potential harm.

Plain-English summary

Fallon Wellness Pharmacy, L.L.C. is recalling 15 vials of Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection. The recall is being conducted because of a lack of assurance of sterility.

The affected product was distributed in New York. The specific lots involved are 1031-2014@51 (expiration date 3/18/15) and 12152014@24 (expiration date 4/12/15).

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

The recalled product

Product
Papaverine/phentolamine/prostaglandin 30/4/0.04 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
15

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 (4)

  • Lot #: a) 1031-2014@51
  • Exp 3/18/15
  • b) 12152014@24
  • 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.

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Same hazard · sterility

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