The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1068-2015·Announced 2015-05-20

Fallon Wellness Pharmacy Recalls Prostaglandin Rx Injections Due to Sterility Concerns

Fallon Wellness Pharmacy is recalling 43 vials of Prostaglandin Rx injections 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 and involves a lack of assurance of sterility in an injectable drug, which poses a risk of serious injury or death if the product is contaminated.

Plain-English summary

Fallon Wellness Pharmacy, L.L.C. is recalling 43 vials of Prostaglandin Rx injections. The product is available in five different concentrations: 10 mcg/mL, 22.5 mcg/mL, 45 mcg/mL, 60 mcg/mL, and 80 mcg/mL. The recall is being conducted because of a lack of assurance of sterility.

The affected product was distributed in New York. The recall includes specific lots with expiration dates ranging from April 12, 2015, to April 27, 2015. The FDA has classified this recall as Class II.

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

The recalled product

Product
Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Manufacturer
Fallon Wellness Pharmacy, L.L.C.
Category
Drug — Injection
Hazard
Affected units
43

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 (10)

  • Lot#: a) 10272014@1
  • Exp 4/27/15
  • b) 11042014@60
  • Exp 4/12/15
  • c) 11192014@43
  • d) 12042014@32
  • e) 12182014@46
  • f) 12232014@8
  • 12242014@16
  • g) 12312014@40

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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