Class I - Dangerous
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Class I - Dangerous
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Class I - Dangerous
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
Nostrum Laboratories
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit