Why it was recalled
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Product description
Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lot numbers, UPCs & expiration codes
Lot #: 180529/2, Exp 27-Aug-18 and 180620/11, Exp 18-Sep-18
Where it was sold
Nationwide in USA
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-1158-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 21, 2018
- FDA report date
- Sep 5, 2018
- Quantity
- 91 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Auro Pharmacies, Inc.
Original FDA data
Every field from FDA enforcement report D-1158-2018, exactly as published.
Show all FDA fields
- City
- La Habra
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 80890
- Address
- 520 W La Habra Blvd
- Code information
- Lot #: 180529/2, Exp 27-Aug-18 and 180620/11, Exp 18-Sep-18
- Postal code
- 90631-5308
- Report date
- Sep 5, 2018
- Product type
- Drugs
- Recall number
- D-1158-2018
- Classification
- Class II
- Recalling firm
- Auro Pharmacies, Inc.
- Product quantity
- 91 vials
- Termination date
- Jan 30, 2020
- Reason for recall
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
- Distribution pattern
- Nationwide in USA
- Recall initiation date
- Aug 21, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 29, 2018