Recalls / Class III
Class IIID-0289-2015
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
- Affected lot / code info
- 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.
Why it was recalled
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 63,648 Bottles
- Distribution pattern
- US Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2014-09-24
- FDA classified
- 2014-12-03
- Posted by FDA
- 2014-12-10
- Terminated
- 2017-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0289-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.