The Recall Desk
LowFDA (Drugs)·D-66373-001·Announced 2013-10-16

Sandoz Recalls Hydroxychloroquine Tablets Due to Illegible Logo

Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets because the logo on some tablets is illegible.

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 defect (illegible logo) with no reported injuries.

Plain-English summary

Sandoz Incorporated is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200 mg. The recall involves 25,830 bottles of the prescription medication, identified by Lot # BU3417 and an expiration date of 06/2014. The product was distributed nationwide.

The recall was initiated because the logo on some tablets is illegible. This issue falls under failed tablet specifications. The source text does not report any illnesses or injuries associated with this recall.

Consumers with this specific lot of medication should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.

The recalled product

Product
Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.
Affected units
25,830

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 #: BU3417
  • Exp 06/2014

Distribution

Distributed nationwide across the United States.