Reported Dec 10, 2014 · Terminated
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad,…
Zydus Pharmaceuticals USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only
- Manufactured byCadila Healthcare Ltd, Ahmedabad, India
- Distributed byZydus Pharmaceuticals USA, Inc
- NDC68382-248-01
- Lot codes and dates
- Lot #: MM8555
- Expiry
09/14Lot #: MM6604
- Expiry
09/14Lot #: MM8551
- Expiry
09/14Lot #: MM8552
- Expiry
09/14Lot #: MM8553
- Expiry
09/14Lot #: MM8554
- Expiry09/14
- Amount recalled
- 63,648 Bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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