Recalls / Class II
Class IID-1068-2015
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
- Affected lot / code info
- 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
Why it was recalled
Lack of assurance of sterility
Recalling firm
- Firm
- Fallon Wellness Pharmacy, L.L.C.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1057 Troy Schenectady Rd, N/A, Latham, New York 12110-1002
Distribution
- Quantity
- 43 vials
- Distribution pattern
- New York
Timeline
- Recall initiated
- 2015-03-17
- FDA classified
- 2015-05-12
- Posted by FDA
- 2015-05-20
- Terminated
- 2018-06-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1068-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.