ZoDen PD recall: CGMP Deviations
ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
Why was ZoDen PD recalled?
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# 11CQ012 Exp 02/13; Lot# 12GQ002 Exp. 06/14.
- Product
- ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
- Recalling firm
- TG United, Inc.
- Quantity
- 4811 - 16 ounce bottles.
- Distribution
- FL, MS, SC, LA and TX
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)