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
Reported: March 20, 2024 Initiated: February 16, 2024 #D-0387-2024
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
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.
Details
- Recalling Firm
- Global Corporation
- Units Affected
- 2345 boxes
- Distribution
- Nationwide within the United States
- Location
- Boca Raton, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Global Corporation. Units affected: 2345 boxes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2024. Severity: Moderate. Recall number: D-0387-2024.
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