Why it was recalled
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Product description
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
US Nationwide including Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0289-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 24, 2014
- FDA report date
- Dec 10, 2014
- Quantity
- 63,648 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0289-2015, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69585
- Address
- 73 Route 31 N
- 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.
- Postal code
- 08534-3601
- Report date
- Dec 10, 2014
- Product type
- Drugs
- Recall number
- D-0289-2015
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 63,648 Bottles
- Termination date
- Jun 21, 2017
- Reason for recall
- Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide including Puerto Rico
- Recall initiation date
- Sep 24, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 3, 2014