Taro Pharmaceuticals Recalls Carbamazepine Tablets Sold Without Approval
Taro Pharmaceuticals is recalling 1,966 bottles of Carbamazepine 200 mg tablets because they were sold without an approved NDA/ANDA.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this recall as Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or regulatory issues.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling 1,966 bottles of Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle. The affected product is identified by Lot 137393 with an expiration date of 10/2016 and NDC 51672-4005-3. The product was distributed in Illinois, Ohio, and Louisiana.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Specifically, one lot was in a hold-pending release status when it was erroneously made available for sale in the inventory control system. Additionally, an alternate manufacturing site for the Carbamazepine API final intermediate was pending approval at the time.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. The FDA classifies this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- CARBAMAZEPINE (CARBAMAZEPINE)
- Brand
- CARBAMAZEPINE
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 1,966
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 137393
- exp. 10/2016
UPCs (3)
- 0351672405014
- 0351672412418
- 0351672404741
Distribution
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