TG United Recalls Z-Dex Pediatric Drops Due to Dosage Deviations
TG United, Inc. is recalling Z-Dex Pediatric 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant potential harm or incorrect dosage issues.
Plain-English summary
TG United, Inc. is recalling 12,988 bottles of Z-Dex Pediatric Drops, Cough Suppressant Decongestant Expectorant. The product is a 16 fl oz. over-the-counter medication manufactured for Trigen Laboratories. The recall is limited to Lot# 11DQ004 with an expiration date of 03/13.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the affected products are underdosed or have an incorrect dosage regime. This issue affects the accuracy of the medication provided to consumers.
The recalled product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers who have this product should stop using it and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30
- Manufacturer
- TG United, Inc.
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 (1)
- Lot# 11DQ004 Exp 03/13.
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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