EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 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
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.
West-Ward Columbus
Class I - Dangerous
Failed Dissolution Specifications:
Class I - Dangerous
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.
West-Ward Columbus
Class I - Dangerous
Failed Dissolution Specifications:
Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Bryant Ranch Prepack
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Bryant Ranch Prepack
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.
Hetero Labs, Ltd. - Unit III
Class I - Dangerous
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Class I - Dangerous
Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
Failed Tablet/Capsule Specifications: Tablet breakage
Class I - Dangerous
Failed Stability Specifications: lot out of specification for elevated water vapor.
Class I - Dangerous
Failed Tablet/Capsule Specifications: Tablet breakage
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.