TG United Recalls ZoDen PD Nasal Spray Due to Dosage Errors
TG United, Inc. is recalling ZoDen PD nasal spray bottles 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, particularly given the risk of incorrect medication dosage.
Plain-English summary
TG United, Inc. is recalling 4,811 16-ounce bottles of ZoDen PD, an over-the-counter antihistamine and nasal decongestant. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically that the products are underdosed or have an incorrect dosage regime.
The affected product is manufactured for Trigen Laboratories in Sayreville, NJ, and carries NDC 13811-0073-16. The recall covers two specific lots: Lot# 11CQ012 with an expiration date of 02/13, and Lot# 12GQ002 with an expiration date of 06/14.
These products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should check their medication for these lot numbers and expiration dates. If they have the affected product, they should stop using it and contact their healthcare provider or the recalling firm for instructions.
The recalled product
- Product
- ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
- 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 (2)
- Lot# 11CQ012 Exp 02/13
- Lot# 12GQ002 Exp. 06/14.
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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