Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
Reported: July 19, 2023 Initiated: July 10, 2023 #D-0914-2023
Product Description
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
Reason for Recall
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 8,880 30-count bottles
- Distribution
- Distributed nationwide in the USA.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 8,880 30-count bottles.
Why was this product recalled? ▼
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2023. Severity: Moderate. Recall number: D-0914-2023.
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