Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Reported: September 28, 2016 Initiated: June 20, 2016 #D-1510-2016
Product Description
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Reason for Recall
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.
Details
- Recalling Firm
- W & C dba The Apothecary
- Units Affected
- 450 mL
- Distribution
- MN
- Location
- Sartell, MN
Frequently Asked Questions
What product was recalled? ▼
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377. Recalled by W & C dba The Apothecary. Units affected: 450 mL.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 28, 2016. Severity: Moderate. Recall number: D-1510-2016.
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