Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
UREA 40% Cream, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Synergy Rx
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
SULFUR 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Synergy Rx
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466
Pharmedium Services
Class I - Dangerous
Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
Amerisource Health Services
Class I - Dangerous
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I - Dangerous
Lack of Assurance of Sterility: There are also CGMP Deviations.