Status
Terminated
Drug Enforcement D-521-2013
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Classification
Class II
Report Date
June 12, 2013
Termination Date
September 30, 2016
Product Information
- Product description
- Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
- Product quantity
- 216,838 bottles - 30 mL
- Reason for recall
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- FL, MS, SC, LA and TX
Location & Firm
- Recalling firm
- TG United, Inc.
- Address
-
16275 Aviation Loop Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-521-2013
- Event ID
- 64188
- Recall initiation date
- January 30, 2013
- Center classification date
- June 4, 2013
- Code info
- Lot# 11CQ001 Exp. 02/13; Lot# 11CQ009 Exp. 02/13; Lot # 11JQ003 Exp. 08/13; Lot# 11JQ004 Exp. 08/23; Lot# 11MQ002 Exp. 11/13.
- More code info
- —