Recalls / Class III
Class IIID-0928-2017
Product
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
- Affected lot / code info
- Lot # 0113148, 0113149, 0113150, Exp: 04/18; 0113636, Exp: 06/18; 0114513, Exp: 10/18
Why it was recalled
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Recalling firm
- Firm
- Mckesson Packaging Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7101 Weddington Rd NW, N/A, Concord, North Carolina 28027-3412
Distribution
- Quantity
- 942 cartons
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2017-05-30
- FDA classified
- 2017-06-29
- Posted by FDA
- 2017-07-05
- Terminated
- 2020-02-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0928-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.