TG United Recalls Brompheniramine/Pseudoephedrine DM Liquid Due to Underdosing
TG United, Inc. is recalling 22,721 bottles of Brompheniramine/Pseudoephedrine DM liquid because the product is underdosed or has an incorrect dosage regime.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the source text explicitly states the products are underdosed or have an incorrect dosage regime, which constitutes a significant risk of harm.
Plain-English summary
TG United, Inc. is recalling 22,721 16-ounce bottles of Brompheniramine/Pseudoephedrine DM liquid. The product is an over-the-counter antihistamine, cough suppressant, and decongestant manufactured for Macoven Pharmaceuticals. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically that the products are underdosed or have an incorrect dosage regime.
The affected lots are 12B001 (Exp. 01/14), 12B002 (Exp. 01/14), and 12F013 (Exp. 05/14). The product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. The National Drug Code (NDC) for the product is 44183-311-16.
Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Cold and Flu
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot# 12B001 Exp. 01/14
- Lot# 12B002 Exp 01/14
- Lot# 12F013 Exp. 05/14
- Lot# 12F013 Exp. 05/14.
Distribution
Part of a larger recall action
This product is one of 44 recalled by TG United, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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