Why it was recalled
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Product description
Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05
Lot numbers, UPCs & expiration codes
Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
Where it was sold
Nationwide
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-0325-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 23, 2014
- FDA report date
- Dec 31, 2014
- Quantity
- 19,536 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0325-2015, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70101
- Address
- 73 Route 31 N
- Code information
- Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
- Postal code
- 08534-3601
- Report date
- Dec 31, 2014
- Product type
- Drugs
- Recall number
- D-0325-2015
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 19,536 units
- Termination date
- Sep 22, 2017
- Reason for recall
- Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 23, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2014