Northwind Pharmaceuticals Recalls Prednisone Tablets Due to Incorrect NDC Labeling
Northwind Pharmaceuticals is recalling 40 bottles of Prednisone 20 mg tablets because the NDC number on the container is incorrect.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error (incorrect NDC number) with no reported injuries or illnesses.
Plain-English summary
Northwind Pharmaceuticals LLC is recalling 40 bottles of Prednisone 20 mg tablets, 10-count, prescription only. The product was manufactured by HIKMA Pharmaceuticals, distributed by West-Ward Pharmaceuticals Corp., and repackaged by Northwind Pharmaceuticals. The specific lot number is NW 46400021 with an expiration date of 03/2018.
The recall was initiated because the National Drug Code (NDC) number printed on the container is incorrect. This is a labeling issue classified as 'Not elsewhere classified.'
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot and NDC number. If found, the product should be returned to the pharmacy or distributor for credit or replacement.
The recalled product
- Product
- Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53
- Manufacturer
- Northwind Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 40
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 # NW 46400021
- Exp 03/2018
Distribution
Distributed nationwide across the United States.
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