Recalls / Class II
Class IID-0474-2021
Product
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP
- Brand name
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride,
- Generic name
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride,
- Active ingredients
- Brompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride
- Route
- Oral
- NDC
- 71930-026
- FDA application
- ANDA211170
- Affected lot / code info
- 13120103A
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Eywa Pharma Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 73 carton
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0474-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.