Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
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.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
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
Affected NDC
44183-0311-16
Compare with the code on your package — it is the most precise check available.
Drug: Ephedrine Category: Allergy & Cold Medication
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ephedrine recalls
See all
Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
Ephedrine Sulfate Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ephedrine 25 Guaifenesin 200 Tablet
CGMP Deviations
Class II · Moderate risk
Ephedrine Plus
cGMP deviations
Other recalls by TG United, Inc.
All 2013 recalls
Class II · Moderate risk
ZoDen PD
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
ZoDen DM Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Z-Dex Syrup
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Z-Dex Pediatric Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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