Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4
Perrigo Company PLC
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility