The Recall Desk
SevereFDA (Drugs)·D-1072-2015·Announced 2015-05-20

Fallon Wellness Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

Fallon Wellness Pharmacy is recalling 4 vials of Papaverine/phentolamine/prostaglandin injection in New York due to 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Fallon Wellness Pharmacy, L.L.C. is recalling 4 vials of Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product is identified by Lot number 12172014@42 and has an expiration date of 4/12/15. The recall is limited to distribution in New York.

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

The recalled product

Product
Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Manufacturer
Fallon Wellness Pharmacy, L.L.C.
Category
Drug — Injectable
Hazard
Affected units
4

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#: 12172014@42
  • 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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