Desmopressin Acetate Tablets Recalled for Incorrect Imprint
American Health Packaging is recalling Desmopressin Acetate Tablets because some are incorrectly imprinted with an X on one side.
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, fitting the 'Low' severity criteria for cosmetic or documentation issues.
Plain-English summary
American Health Packaging is recalling Desmopressin Acetate Tablets, 0.1 mg, Rx Only, packed in 30 tablet cartons. The recall involves 341 cartons of the product, identified by Lot #151360 and an expiration date of 12/31/2016. The product was distributed nationwide in the United States.
The recall was initiated because some of the tablets were incorrectly imprinted with an X on one side. This is a Class III recall, indicating that the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected tablets and return them to the pharmacy or point of purchase for a refund or replacement. The NDC for the affected product is 68084-606-21.
The recalled product
- Product
- Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 341
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 #:151360
- Expiry: 12/31/2016
Distribution
Distributed nationwide across the United States.
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