Recalls / Class II
Class IID-1511-2016
Product
Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
- Affected lot / code info
- LOT #: 06201604@15, 19201602@3, 06201604@8
Why it was recalled
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Recalling firm
- Firm
- W & C dba The Apothecary
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 165 19th St S, Suite 102, Sartell, Minnesota 56377-2567
Distribution
- Quantity
- 600 mL
- Distribution pattern
- MN
Timeline
- Recall initiated
- 2016-06-20
- FDA classified
- 2016-09-16
- Posted by FDA
- 2016-09-28
- Terminated
- 2017-04-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1511-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.