Why it was recalled
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Product description
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.
Lot numbers, UPCs & expiration codes
Lot #s: 6114311, 6114717, Exp 05/18
Where it was sold
Nationwide in the 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-0668-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 8, 2017
- FDA report date
- Apr 19, 2017
- Quantity
- 98 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Medical Surgical
Original FDA data
Every field from FDA enforcement report D-0668-2017, exactly as published.
Show all FDA fields
- City
- Henrico
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 76863
- Address
- 9954 Mayland Dr
- Code information
- Lot #s: 6114311, 6114717, Exp 05/18
- Postal code
- 23233-1464
- Report date
- Apr 19, 2017
- Product type
- Drugs
- Recall number
- D-0668-2017
- Classification
- Class II
- Recalling firm
- Mckesson Medical Surgical
- Product quantity
- 98 vials
- Termination date
- Aug 19, 2024
- Reason for recall
- Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 8, 2017
- Initial firm notification
- Telephone
- Center classification date
- Apr 12, 2017