Breckenridge Recalls Megestrol Acetate Oral Suspension for Stability Failures
Breckenridge Pharmaceutical is recalling Megestrol Acetate Oral Suspension due to out-of-specification particle size results during stability testing.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling specific lots of Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottles. The product is distributed nationwide within the United States and is manufactured by Pharmaceutics International Inc.
The recall was initiated because the product failed stability specifications. Specifically, out-of-specification results were obtained for particle size distribution during stability testing. The affected lots are 5599.008A, 5599.009A, 5599.010A (Exp. 04/2019), 5599.012A, 5599.013A (Exp. 11/2019), and 5599.014A (Exp. 01/2020).
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Patients and healthcare providers should check their inventory for the affected lot numbers and contact the recalling firm for further instructions.
The recalled product
- Product
- Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug — Oral Suspension
- Hazard
- Affected units
- 9,193
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 (9)
- Lot #: 5599.008A
- 5599.009A
- 5599.010A
- Exp. 04/2019
- 5599.012A
- 5599.013A
- Exp. 11/2019
- 5599.014A
- Exp. 01/2020
Distribution
Distributed nationwide across the United States.
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