Sun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
Sun Pharmaceutical Industries is recalling 1,968 bottles of Carbamazepine 200mg tablets due to CGMP deviations and black spots found on tablets.
What this means for you
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: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without reported hospitalizations or injuries fall into the High severity category (Score 3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 1,968 bottles of Carbamazepine Tablets, USP, 200mg (NDC 51672-4005-3). The affected product is Lot # AD94033 with an expiration date of 5/31/2028. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the discovery of black spots on tablets resulting from burnt excipient during the manufacturing process.
The affected product was distributed nationwide in the United States. The tablets are prescription-only and are manufactured by Taro Pharmaceutical Industries Ltd. and distributed by Taro Pharmaceuticals USA, Inc.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for a replacement. The recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CARBAMAZEPINE (CARBAMAZEPINE)
- Brand
- CARBAMAZEPINE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Medication
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 # AD94033
- Exp Date: 5/31/2028.
UPCs (3)
- 0351672405014
- 0351672412418
- 0351672404741
Distribution
Distributed nationwide across the United States.
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