McKesson Recalls Propafenone Hydrochloride Tablets for Moisture Content Issues
McKesson Packaging Services is recalling Propafenone Hydrochloride tablets due to failed moisture limits. The affected units were distributed to five states.
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 by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
McKesson Packaging Services is recalling Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box). The recall was initiated because the product failed moisture limits, resulting in out-of-specification moisture content.
The affected product was manufactured by Watson Pharmaceuticals and distributed to Pennsylvania, Ohio, Illinois, Colorado, and Louisiana. The recall involves 3,966 unit-dose boxes with specific lot numbers and expiration dates ranging from December 2017 to February 2019.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The U.S. Food and Drug Administration 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.
The recalled product
- Product
- Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10
- Manufacturer
- Mckesson Packaging Services
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,966
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 (3)
- Lot#: 0112313 Exp. 12/2017
- 0113376 Exp. 06/2018
- 0113645 Exp. 02/2019.
Distribution
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