Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
McKesson Packaging Services
Class I - Dangerous
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class I - Dangerous
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class I - Dangerous
Failed Stability Specifications
Subpotent Drug: Out of specification for assay (stability testing)
Failed moisture limits: Out of specification for moisture content.
Class I - Dangerous
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Supotent: Out of Specification result for assay test during routine stability testing.
Presence of Foreign Substance: foreign material found in the bulk inventory.
Class I - Dangerous
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).
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.
Class I - Dangerous
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Class I - Dangerous
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class I - Dangerous
Failed Dissolution Specification; at the 12 month time interval.
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.