Why it was recalled
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Product description
Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)
Lot numbers, UPCs & expiration codes
AHP lot number 145513, exp 6/2016
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-0430-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 6, 2015
- FDA report date
- Apr 8, 2015
- Quantity
- 2284 cartons (100 individual unit doses per carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0430-2015, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 70320
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- AHP lot number 145513, exp 6/2016
- Postal code
- 43217-1188
- Report date
- Apr 8, 2015
- Product type
- Drugs
- Recall number
- D-0430-2015
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 2284 cartons (100 individual unit doses per carton)
- Termination date
- Jul 23, 2015
- Reason for recall
- Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 6, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 1, 2015