FDAClass IIMay 20, 2015

Prostaglandin recall: Sterility Concern

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…

Why was Prostaglandin recalled?

Lack of assurance of sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Fallon Wellness Pharmacy, L.L.C.
Quantity
43 vials
Distribution
New York
Recall date
May 20, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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