Class II · Moderate risk
Megestrol Acetate Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Megestrol Acetate Oral Suspension
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Out of specification for assay (stability testing)
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
63739-0549-51
Compare with the code on your package — it is the most precise check available.
Drug: Megestrol
- Recalling firm
- Mckesson Packaging Services
- NDC code
- 63739-549-51
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0338-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Megestrol recalls
See all
Class III · Low risk
Megestrol Acetate Oral Suspension
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Class II · Moderate risk
Megestrol Acetate Oral Suspension
Supterpotent Drug
Other recalls by Mckesson Packaging Services
All 2018 recalls
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk
Diltiazem CD
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class II · Moderate risk
RANITIDINE Tablets
Failed Stability Specifications
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