Oxcarbazepine 600mg tablets recalled for foreign substance contamination
Sun Pharmaceutical is recalling three lots of Oxcarbazepine 600mg tablets due to the presence of foreign substances. The affected medication was distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall. Foreign substance contamination in a prescription medication poses a risk of harm, but no illnesses or injuries have been reported. The score reflects a significant contamination hazard in a medication without documented patient harm.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling specific lots of Oxcarbazepine 600mg tablets due to the presence of foreign substances. The affected lots (HAC1474A, HAC1474B, and HAC1503A) were distributed nationwide in the United States and have an expiration date of 03/2023.
Oxcarbazepine is a prescription medication used to treat seizure disorders. The affected product is available in 100-count, 500-count, and 1000-count bottles with the following National Drug Codes (NDCs): 62756-185-88, 62756-185-13, and 62756-185-18.
Patients who have received any of the recalled lots should consult their healthcare provider or pharmacist. The FDA is monitoring this recall and working with the manufacturer to ensure all affected product is properly identified and managed.
The recalled product
- Product
- OXCARBAZEPINE (OXCARBAZEPINE)
- Brand
- OXCARBAZEPINE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Anti-epileptic
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 (4)
- a) Lot HAC1474A
- Expires 03/2023 b) Lot HAC1503A
- Expires 03/2023 c) Lot HAC1474B
- Expires 03/2023
UPCs (3)
- 0362756183834
- 0362756185838
- 0362756184831
Distribution
Distributed nationwide across the United States.
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