Recalls of antidepressants, anti-anxiety and related psychiatric medications.
224 recalls in this category, newest first.
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
Failed Dissolution Specifications
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Lack of Processing Controls
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Labeling: Incorrect or Missing Lot and/or Expiration Date
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
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