Class I - Dangerous
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89
Teva Pharmaceuticals USA
Class I - Dangerous
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3
NuCare Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
NuCare Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
NuCare Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.