Why it was recalled
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 17180918, EXP June 2020
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-0349-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 27, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 5,016 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0349-2019, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81639
- Address
- 750 Corporate Dr
- Code information
- Lot: 17180918, EXP June 2020
- Postal code
- 07430-2009
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0349-2019
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 5,016 blister packs
- Termination date
- Sep 12, 2019
- Reason for recall
- Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 27, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 7, 2019