Why it was recalled
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Product description
BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
Lot numbers, UPCs & expiration codes
Lot # 0113148, 0113149, 0113150, Exp: 04/18; 0113636, Exp: 06/18; 0114513, Exp: 10/18
Where it was sold
Nationwide in the US
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-0928-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 30, 2017
- FDA report date
- Jul 5, 2017
- Quantity
- 942 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Packaging Services
Original FDA data
Every field from FDA enforcement report D-0928-2017, exactly as published.
Show all FDA fields
- City
- Concord
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 77411
- Address
- 7101 Weddington Rd NW
- Code information
- Lot # 0113148, 0113149, 0113150, Exp: 04/18; 0113636, Exp: 06/18; 0114513, Exp: 10/18
- Postal code
- 28027-3412
- Report date
- Jul 5, 2017
- Product type
- Drugs
- Recall number
- D-0928-2017
- Classification
- Class III
- Recalling firm
- Mckesson Packaging Services
- Product quantity
- 942 cartons
- Termination date
- Feb 6, 2020
- Reason for recall
- Failed Moisture Limits: Product tested out-of-specification for moisture content.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- May 30, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2017