Drug Enforcement D-0387-2024

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 & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12
Product quantity
2345 boxes
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-0387-2024
Event ID
94015
Recall initiation date
February 16, 2024
Center classification date
March 14, 2024
Code info
Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025
More code info
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