Mckesson Packaging Services Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL recall — FDA D-0338-2018
Subpotent Drug: Out of specification for assay (stability testing)
Overview of recall records associated with Mckesson Packaging Services, including dates, categories and classifications where available.
Classification mix: Class III: 8, Class II: 1.
Subpotent Drug: Out of specification for assay (stability testing)
Failed moisture limits: 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.
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.
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.
This page summarizes recall records in which the official source identifies Mckesson Packaging Services as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.