McKesson Recalls Subpotent Megestrol Acetate Oral Suspension
McKesson Packaging Services is recalling Megestrol Acetate Oral Suspension because stability testing found the drug was subpotent.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a critical allergen.
Plain-English summary
McKesson Packaging Services is recalling Megestrol Acetate Oral Suspension, USP 400 mg/10mL. The product is distributed in 10 mL UD cups in boxes of 20 cups and is available by prescription only.
The recall was initiated because the product failed stability testing for assay, meaning it was found to be subpotent. The affected lot number is 0114588 with an expiration date of 10/18. The total quantity involved is 24,120 cups, which were distributed nationwide in the United States.
Patients and healthcare providers should check their inventory for this specific lot number. If found, the product should be discontinued and returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51
- Manufacturer
- Mckesson Packaging Services
- Category
- Drug — Oral Suspension
- Hazard
- Affected units
- 24,120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 0114588
- Exp 10/18
Distribution
Distributed nationwide across the United States.
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