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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
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