Drug Enforcement D-0251-2025

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Status

Ongoing

Classification

Class II

Report Date

March 12, 2025

Termination Date

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Product Information

Product description
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
Product quantity
10992 Oral Syringes
Reason for recall
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Safecor Health, LLC
Address
4060 Business Park Dr Ste B

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0251-2025
Event ID
96308
Recall initiation date
February 17, 2025
Center classification date
March 5, 2025
Code info
Lot #s: 24201295, Exp 02/05/2025; 24210364, Exp 02/20/2025; 24231720, Exp 02/27/2025; 24500770, Exp 06/26/2025; 24471182, Exp 06/20/2025; 25031031, Exp 07/22/2025.
More code info
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