FDAFDA · Food and drugs·Recall number D-0289-2015
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
Published December 10, 2014 · Recall initiated: September 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Distributor
- US Nationwide including Puerto Rico
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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