Drug product
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
D-0289-2015
Product summary
- Event
- Event 69585
- Status
- Terminated
- Classification
- Class III
- Quantity
- 63,648 Bottles
- Official record key
drug-enforcement:D-0289-2015
Official wording
Reason: Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Code information: Lot #: MM8555, Expiry: 09/14; Lot #: MM6604, Expiry: 09/14; Lot #: MM8551, Expiry: 09/14; Lot #: MM8552, Expiry: 09/14; Lot #: MM8553, Expiry: 09/14; Lot #: MM8554, Expiry: 09/14.
Distribution pattern: US Nationwide including Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Capsules