Reported Jun 12, 2013 · Terminated
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC,…
TG United, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TG United, Inc. · 16275 Aviation Loop Dr · Brooksville, FL · 34604-6805
Is this the product you have?
- BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC
- Manufactured forMacoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
- Lot codes and dates
Lot# 12B001 Exp. 01/14Lot# 12B001 Exp. 01/14Lot# 12B002 Exp 01/14Lot# 12F013 Exp. 05/14Lot# 12F013 Exp. 05/14
- Amount recalled
- 22,721 - 16 ounce bottles
This recall covers 44 products
The agency filed one notice per product. You are reading one of them; the other 43 are below.
31 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
This product could cause temporary or reversible health problems — stop using it.
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