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.
Product description
Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Lot numbers, UPCs & expiration codes
LOT #: 12201604@21
Where it was sold
MN
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-1508-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 20, 2016
- FDA report date
- Sep 28, 2016
- Quantity
- 40,000 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- W & C dba The Apothecary
Original FDA data
Every field from FDA enforcement report D-1508-2016, exactly as published.
Show all FDA fields
- City
- Sartell
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 74606
- Address
- 165 19th St S
- Address (line 2)
- Suite 102
- Code information
- LOT #: 12201604@21
- Postal code
- 56377-2567
- Report date
- Sep 28, 2016
- Product type
- Drugs
- Recall number
- D-1508-2016
- Classification
- Class II
- Recalling firm
- W & C dba The Apothecary
- Product quantity
- 40,000 mL
- Termination date
- Apr 19, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
- Distribution pattern
- MN
- Recall initiation date
- Jun 20, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 16, 2016