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

FDA recall notice · announced December 10, 2014 · Zydus Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.

Notes

Distribution: US Nationwide including Puerto Rico
Lot/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.
Quantity: 63,648 Bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.