The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1172-2018·Announced 2018-09-12

McKesson Recalls Megestrol Acetate Oral Suspension Due to Supra-Potent Drug

McKesson is recalling 1,531 cartons of Megestrol Acetate Oral Suspension because the drug is supra-potent. The recall is voluntary and nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the 'supra-potent' nature of the drug implies a significant risk of adverse health consequences, aligning with the Severe classification for Class II recalls involving significant risks.

Plain-English summary

McKesson Corporation is voluntarily recalling 1,531 cartons of Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL. 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 drug is supra-potent.

The affected product was manufactured by Par Pharmaceutical and distributed by McKesson Packaging Services. The recall covers lots 0116158 (expiration 4/30/19), 0113903, 0113902, and 0113901 (expiration 8/31/18). The product was distributed nationwide within the United States.

The FDA has classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations.

The recalled product

Product
Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord…
Manufacturer
Mckesson Corporation
Category
Drug — Oral Suspension
Hazard
Affected units
1,531

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 (5)

  • Lot #: 0116158 Exp. 4/30/19
  • 0113903
  • 0113902
  • 0113901
  • Exp. 8/31/18

Distribution

Distributed nationwide across the United States.

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