Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Hetero Drugs Ltd. - Unit 1
Class I - Dangerous
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Fresenius Kabi USA
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class I - Dangerous
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
Class I - Dangerous
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Class I - Dangerous
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..