FDA Recall D-0387-2024

Global Corporation · Boca Raton, FL

Class II Ongoing 818 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025

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 record

Recall number: D-0387-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide within the United States
Recall initiated: 2024-02-16
Classified by FDA Center: 2024-03-14
FDA published: 2024-03-20
Recalling firm: Global Corporation
Firm location: Boca Raton, FL

Drug identification

Brand name(s): BRONCOCHEM
Generic name(s): ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE
Manufacturer(s): LABORATORIO MAGNACHEM INTERNATIONAL SRL
NDC(s): 65131-097
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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