The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0174-2017·Announced 2016-12-14

Fallon Wellness Pharmacy Recalls PAPA/PHEN/PROST Injection Due to Sterility Concerns

Fallon Wellness Pharmacy is recalling 5 vials of PAPA/PHEN/PROST injection due to environmental monitoring excursions that raise concerns about sterility assurance.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential sterility failures in injectable products which carry significant risk.

Plain-English summary

Fallon Wellness Pharmacy, L.L.C. is recalling 5 vials of PAPA/PHEN/PROST (papaverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection. The product is packaged in 1 mL vials. The specific lot number is 09202016@8 with an expiration date of 11/04/2016.

The recall was initiated because the product was produced on a day when there was an excursion in environmental monitoring data. This event raises a lack of assurance regarding the sterility of the product. The FDA has classified this recall as Class II.

The affected product was distributed in New York (NY). Consumers who possess this specific lot of medication should contact their healthcare provider or the recalling firm for further instructions on how to proceed.

The recalled product

Product
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.
Manufacturer
Fallon Wellness Pharmacy, L.L.C.
Category
Drug — Injectable
Hazard
Affected units
5

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 #: 09202016@8
  • Exp 11/04/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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