BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
Reported: December 10, 2014 Initiated: September 24, 2014 #D-0289-2015
Product Description
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
Reason for Recall
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 63,648 Bottles
- Distribution
- US Nationwide including Puerto Rico
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 63,648 Bottles.
Why was this product recalled? ▼
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 10, 2014. Severity: Low. Recall number: D-0289-2015.
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