Class II · Moderate risk
HydrALAZINE Hydrochloride
Failed Impurities/Degradation Specifications
hydrALAZINE HYDROCHLORIDE INJECTION
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
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.
Affected NDC
63323-0614-01
Compare with the code on your package — it is the most precise check available.
Drug: Hydralazine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Hydralazine Hydrochloride NDC 63323-0614 |
20 mg/mL | Injection Intramuscular|intravenous |
Fresenius Kabi USA, LLC | Rx |
- Recalling firm
- Mckesson Medical Surgical
- NDC code
- 63323-614-01
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0668-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydralazine recalls
See all
Class II · Moderate risk
HydrALAZINE Hydrochloride
Failed Impurities/Degradation Specifications
Class III · Low risk
Hydralazine HCl Tablets
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class II · Moderate risk
HydrALAZINE Hydrochloride Tablets
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Class III · Low risk
HydrALAZINE Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Other temperature excursion recalls from 2017
All temperature excursion recalls
Class II · Moderate risk
Famciclovir Tablets
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Class I · High risk
Intralipid 20%
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
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