Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
Reported: March 25, 2015 Initiated: January 23, 2015 #D-0413-2015
Product Description
Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
Reason for Recall
Subpotent Drug and Failed Impurities/Degradation Specifications
Details
- Recalling Firm
- Mylan Institutional LLC
- Units Affected
- 78,090 vials
- Distribution
- Nationwide
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10. Recalled by Mylan Institutional LLC. Units affected: 78,090 vials.
Why was this product recalled? ▼
Subpotent Drug and Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 25, 2015. Severity: Low. Recall number: D-0413-2015.
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