The Recall Desk
SevereFDA (Drugs)·D-0261-2019·Announced 2018-11-21

Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

Sandoz Inc. is recalling 1,550 bottles of Isosorbide Dinitrate Tablets 20 mg due to cross-contamination with other products.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating (score 4) under the provided rubric, particularly given the risk of cross-contamination in a prescription medication.

Plain-English summary

Sandoz Inc. is recalling 1,550 bottles of Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles. The product is prescription-only and was manufactured by Sandoz Inc. in Princeton, NJ, for BluePoint Laboratories under NDC 68001-222-00.

The recall was initiated because of cross-contamination with other products. The affected lot number is JA9534, with an expiration date of 05/2021. The product was distributed nationwide within the United States.

Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
Manufacturer
Sandoz Inc
Category
Drug — Prescription Medication
Hazard
Affected units
1,550

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 #: JA9534
  • Exp. 05/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Sandoz Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Sandoz Inc

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Same hazard · cross contamination

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