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Recall Observatory FDA recall evidence

Drug 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

D-0928-2017

May 30, 2017

Class III

Product summary

Firm
Mckesson Packaging Services
Event
Event 77411
Status
Terminated
Classification
Class III
Quantity
942 cartons
Official record key
drug-enforcement:D-0928-2017

Official wording

Reason: Failed Moisture Limits: Product tested out-of-specification for moisture content.

Code information: Lot # 0113148, 0113149, 0113150, Exp: 04/18; 0113636, Exp: 06/18; 0114513, Exp: 10/18

Distribution pattern: Nationwide in the US

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification