← FDA ENFORCEMENT
D-0411-2024Class II

SCA Pharmaceuticals, LLC

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
2,458, syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028

Code / lot info

Lot #: 1223047334 Exp 12/23/23; 1223048170 Exp 02/01/24

Other recalls SPEQ maps to Environmental Monitoring
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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.