Why it was recalled
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 09202016@8, Exp 11/04/2016
Where it was sold
NY
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-0174-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 2, 2016
- FDA report date
- Dec 14, 2016
- Quantity
- 5 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fallon Wellness Pharmacy, L.L.C.
Original FDA data
Every field from FDA enforcement report D-0174-2017, exactly as published.
Show all FDA fields
- City
- Latham
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 75695
- Address
- 1057 Troy Schenectady Rd
- Code information
- Lot #: 09202016@8, Exp 11/04/2016
- Postal code
- 12110-1002
- Report date
- Dec 14, 2016
- Product type
- Drugs
- Recall number
- D-0174-2017
- Classification
- Class II
- Recalling firm
- Fallon Wellness Pharmacy, L.L.C.
- Product quantity
- 5 vials
- Termination date
- Jun 19, 2018
- Reason for recall
- Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- NY
- Recall initiation date
- Nov 2, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 8, 2016