CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
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CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
Brian P. Richardson
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Defective container: Ineffective seal between the cap and jar of the affected product.
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3.
MSM Nutraceuticals
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.