TG United Recalls Cardec DM Drops Due to Underdosing
TG United, Inc. is recalling Cardec DM Drops because the products are underdosed or have an incorrect dosage regime.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving dosage errors that could impact therapeutic efficacy or safety.
Plain-English summary
TG United, Inc. is voluntarily recalling Cardec DM Drops, an over-the-counter decongestant, antihistamine, and antitussive. The recall involves 216,838 bottles of the 30 mL product. The affected lots are 11CQ001, 11CQ009, 11JQ003, 11JQ004, and 11MQ002.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products are underdosed or have an incorrect dosage regime. The agency has classified this recall as Class II.
The affected products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should stop using the recalled product and return it to the point of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Cough and Cold
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 (5)
- Lot# 11CQ001 Exp. 02/13
- Lot# 11CQ009 Exp. 02/13
- Lot # 11JQ003 Exp. 08/13
- Lot# 11JQ004 Exp. 08/23
- Lot# 11MQ002 Exp. 11/13.
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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