← FDA ENFORCEMENT
D-0141-2024Class II

Wells Pharma of Houston LLC

Recalling firm
Wells Pharma of Houston LLC
Product type
Drug
Status
Completed
Report date
2023-12-13
Distribution
Philadelphia, Pennsylvania.
Firm state
TX
Product quantity
825 syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of assurance of sterility.

Product description

ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10

Code / lot info

Lot # 11092313110#01, Exp 01/12/24

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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.