Recalls / Class III
Class IIID-0349-2019
Product
Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40
- Brand name
- Aprepitant
- Generic name
- Aprepitant
- NDCs
- 68462-112, 68462-583, 68462-584, 68462-585
- FDA application
- ANDA207777
- Affected lot / code info
- Lot: 17180918, EXP June 2020
Why it was recalled
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 5,016 blister packs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-11-27
- FDA classified
- 2019-01-07
- Posted by FDA
- 2018-12-26
- Terminated
- 2019-09-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0349-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.