D-517-2013 Class II Terminated
FDA drug recall D-517-2013 was initiated by TG United, Inc. on Jan 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 Sep 30, 2016). Affected quantity: 31,739 bottles 100-count; 842,617 Bulk tablet bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 12, 2013
- Initiation Date
- Jan 30, 2013
- Termination Date
- Sep 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,739 bottles 100-count; 842,617 Bulk tablet bottles
Product Description
Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01
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# 11L006 Exp. 10/13; Lot# 11L006 Exp. 10/13; Lot# 12B003 Exp 01/14; Lot# 12B003 Exp. 01/14; Lot#12D005 Exp. 03/14; Lot# 12D005 Exp. 03/14; Lot# 12H001 Exp. 07/14.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-517-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026