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.

FDA recall notice · announced August 28, 2019 · Sca Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the U.S.
Lot/code information: Lot #: 1219010961, Exp. 10/24/2019
Quantity: 922 syringes
Status: Terminated
Products in this recall event:
- 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. (D-1843-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.