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Superpotent and Subpotent drugs
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
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).
The dietary supplement Brain ECM contains lead.
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Failed Dissolution Specifications
Box labeled Thiamine Hydrochloride instead of Thiamine Mononitrate
Superpotent Drug and Subpotent Drug; potency failures obtained
Microbial Contamination of Non-Sterile Product
The lots exceed the label claim for Vitamin D3 of 2000 IU per drop.
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.
Defective delivery system: detached needles on the syringe in the kit.
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack