Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination
Sandoz Inc. is recalling 5,100 bottles of Isosorbide Dinitrate Tablets, USP 10 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, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported, the 'never go below 4' rule for Class I/II structural/contamination issues in the rubric context (specifically 'FDA Class II with hospitalization reports' or similar high-risk structural issues) aligns with a Severe rating for cross-contamination of a prescription drug.
Plain-English summary
Sandoz Inc. is recalling 5,100 bottles of Isosorbide Dinitrate Tablets, USP 10 mg, 100-count bottles, Rx Only. The product is manufactured by Sandoz Inc. in Princeton, NJ, for BluePoint Laboratories under NDC 68001-225-00. The specific lot affected is JA3077 with an expiration date of 05/2021.
The recall was initiated because the product was subject to cross contamination with other products. The agency has classified this recall as Class II, indicating a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The affected product was distributed nationwide within the United States. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations for prescription medications.
The recalled product
- Product
- Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
- Manufacturer
- Sandoz Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,100
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 #: JA3077
- 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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