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Product manufactured with cumin that may contain peanut protein.
Subpotent Drug and Failed Impurities/Degradation Specifications
Bottles contained a vegetarian digestive enzyme dietary supplement instead of melatonin.
Subpotent Drug
The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5 blister cards inside a carton was missing some or all of the product information on the back of the blister card.
Lack of sterility assurance.
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01.
Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Product contains undeclared preservatives, Benzoic Acid and Sorbic Acid.
The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.
Firm's sodium claims of 55 g/serving is incorrect. Product analyzed and found to contain shows approx. 290 mg/serving size
Firm's sodium claims of 55 g/serving is incorrect. Product analyzed and found to contain shows 260 - 290 mg/serving size
Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.