← FDA ENFORCEMENT
D-0416-2024Class 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
1,118 syringes in kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck

Code / lot info

Lot #: 1223048431 exp 04/05/24; 1223049023 exp 04/25/24

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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.