Drug product
aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089
D-1053-2016
Product summary
- Firm
- The Aloe Source
- Event
- Event 74146
- Status
- Terminated
- Classification
- Class II
- Quantity
- 577 (212 1 fl oz.. plastic bottles, 167 8 fl oz. plastic bottles, 198 8 fl oz. plastic tubes)
- Official record key
drug-enforcement:D-1053-2016
Official wording
Reason: CGMP Deviations
Code information: Lot # 1407012; Exp. 03/17
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations