Why it was recalled
Lack of assurance of sterility
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
New York
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1068-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 17, 2015
- FDA report date
- May 20, 2015
- Quantity
- 43 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fallon Wellness Pharmacy, L.L.C.
Original FDA data
Every field from FDA enforcement report D-1068-2015, exactly as published.
Show all FDA fields
- City
- Latham
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 70807
- Address
- 1057 Troy Schenectady Rd
- Code information
- 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
- Postal code
- 12110-1002
- Report date
- May 20, 2015
- Product type
- Drugs
- Recall number
- D-1068-2015
- Classification
- Class II
- Recalling firm
- Fallon Wellness Pharmacy, L.L.C.
- Product quantity
- 43 vials
- Termination date
- Jun 5, 2018
- Reason for recall
- Lack of assurance of sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- New York
- Recall initiation date
- Mar 17, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 12, 2015