D-511-2013 Class II Terminated
FDA drug recall D-511-2013 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: 348 - 16 ounce 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
- 348 - 16 ounce bottles
Product Description
AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16
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 # 12HQ004, 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-511-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026