Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
Reported: August 28, 2019 Initiated: August 16, 2019 #D-1843-2019
Product Description
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
Reason for Recall
Lack of Assurance of Sterility.
Details
- Recalling Firm
- SCA Pharmaceuticals, LLC
- Units Affected
- 922 syringes
- Distribution
- Nationwide in the U.S.
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.. Recalled by SCA Pharmaceuticals, LLC. Units affected: 922 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 28, 2019. Severity: Moderate. Recall number: D-1843-2019.
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