Recalling firm
SCA Pharmaceuticals, LLC
Product type
Drug
Status
Terminated
Report date
2024-04-03
Distribution
Nationwide in the USA
Firm state
CT
Product quantity
3,671 syringes, expanded 1,911 syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Assurance of Sterility
Product description
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
Code / lot info
Lot #: 1223045974 Exp 12/18/23; 1223046535 Exp 01/11/24; 1223049152 Exp 05/02/24 Expanded Lot #: 1223048067, Exp 04/06/2024; 1223048792, Exp 04/17/2024.
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.