Class II · Moderate risk Terminated
ePHEDrine in 0.9% sodium chloride
Reason Lack of assurance of sterility:
Brompheniramine/Pseudoephedrine Dm
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
What was recalled
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
- Recalling firm
- TG United, Inc.
- NDC code
- 44183-311-16
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-519-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ephedrine recalls
See all
Class II · Moderate risk Terminated
ePHEDrine in 0.9% sodium chloride
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Ongoing
Ephedrine Sulfate Injection
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator
Reason Short Fill
Class III · Low risk Terminated
Allergy Relief D
Reason Failed dissolution specifications
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