D-546-2013 Class II Terminated
FDA drug recall D-546-2013 was initiated by TG United, Inc. on January 30, 2013 and is designated Class II. Reason for recall: CGMP Deviations: Products are underdosed or have an incorrect dosage regime. The recall status is terminated (terminated September 30, 2016). Affected quantity: 4811 - 16 ounce bottles..
Recall Details
- Product Type
- Drugs
- Report Date
- June 12, 2013
- Initiation Date
- January 30, 2013
- Termination Date
- September 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4811 - 16 ounce bottles.
Product Description
ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Distribution Pattern
FL, MS, SC, LA and TX
Code Information
Lot# 11CQ012 Exp 02/13; Lot# 12GQ002 Exp. 06/14.