Recalls / Class II
Class IID-0430-2015
Product
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)
- Brand name
- Benzonatate
- Generic name
- Benzonatate
- Active ingredient
- Benzonatate
- Route
- Oral
- NDC
- 68084-214
- FDA application
- ANDA040597
- Affected lot / code info
- AHP lot number 145513, exp 6/2016
Why it was recalled
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 2284 cartons (100 individual unit doses per carton)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-01-06
- FDA classified
- 2015-04-01
- Posted by FDA
- 2015-04-08
- Terminated
- 2015-07-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0430-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.