Drug product
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
D-0387-2024
Product summary
- Event
- Event 94015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2345 boxes
- Official record key
drug-enforcement:D-0387-2024
Official wording
Reason: 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.
Code information: Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
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.