Recalls / Class II
Class IID-0668-2017
Product
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.
- Brand name
- Hydralazine Hydrochloride
- Generic name
- Hydralazine Hydrochloride
- Active ingredient
- Hydralazine Hydrochloride
- Route
- Intramuscular, Intravenous
- NDC
- 63323-614
- FDA application
- ANDA040388
- Affected lot / code info
- Lot #s: 6114311, 6114717, Exp 05/18
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.
Recalling firm
- Firm
- Mckesson Medical Surgical
- Manufacturer
- Fresenius Kabi USA, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 9954 Mayland Dr, N/A, Henrico, Virginia 23233-1464
Distribution
- Quantity
- 98 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-03-08
- FDA classified
- 2017-04-12
- Posted by FDA
- 2017-04-19
- Terminated
- 2024-08-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0668-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.