Drug Enforcement D-0386-2024

Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

Status

Ongoing

Classification

Class II

Report Date

March 20, 2024

Termination Date

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Product Information

Product description
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44
Product quantity
9831 bottles
Reason for recall
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Global Corporation
Address
621 Nw 53rd St Ste 240, N/A

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

Codes & Dates

Recall number
D-0386-2024
Event ID
94015
Recall initiation date
February 16, 2024
Center classification date
March 14, 2024
Code info
Lot #: 223002, Exp. Date 10/2025; 223063, Exp. Date 02/2026
More code info
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