Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
Reported: October 24, 2018 Initiated: September 20, 2018 #D-0082-2019
Product Description
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
Reason for Recall
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 1,373 60-count cartons
- Distribution
- Product was distributed throughout the United States to various distributors who may have further distributed the product.
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96. Recalled by Teva Pharmaceuticals USA. Units affected: 1,373 60-count cartons.
Why was this product recalled? ▼
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 24, 2018. Severity: Moderate. Recall number: D-0082-2019.
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