Actavis Recalls Desmopressin Acetate Tablets with Incorrect Imprint
Actavis is recalling 11,445 bottles of Desmopressin Acetate Tablets because some tablets are incorrectly imprinted with an X.
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 cosmetic imprint error, not a functional or safety defect.
Plain-English summary
Actavis Laboratories, FL, Inc. is recalling 11,445 bottles of Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles. The product is distributed nationwide in the U.S., including Puerto Rico. The specific lot number is 982021M, with an expiration date of December 2016.
The recall was initiated because some tablets in the affected lot are 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 who have this product should contact their healthcare provider or pharmacist for guidance on how to proceed. The product is prescription-only, so patients should not attempt to self-manage the recall without professional advice.
The recalled product
- Product
- Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.
- Manufacturer
- Actavis Laboratories, FL, Inc.
- Category
- Drug — Tablets
- Hazard
- Affected units
- 11,445
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 # 982021M
- Expiry: DEC. 2016
Distribution
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