The Recall Desk
LowFDA (Drugs)·D-1285-2015·Announced 2015-08-12

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.

What this means for you

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.
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

Distributed nationwide across the United States.

The notice also names 1 state specifically: