Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Reported: May 15, 2024 Initiated: April 24, 2024 #D-0491-2024
Product Description
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Reason for Recall
Discoloration: Dotted and yellow spots on tablets
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 6696 bottles
- Distribution
- Nationwide in the USA
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.. Recalled by Aurobindo Pharma USA Inc.. Units affected: 6696 bottles.
Why was this product recalled? ▼
Discoloration: Dotted and yellow spots on tablets
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 15, 2024. Severity: Moderate. Recall number: D-0491-2024.
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