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Recall Observatory FDA recall evidence

Drug product

Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01

D-578-2013

March 19, 2013

Class III

Product summary

Firm
Teva Pharmaceuticals USA, Inc.
Event
Event 64680
Status
Terminated
Classification
Class III
Quantity
68,322 bottles
Official record key
drug-enforcement:D-578-2013

Official wording

Reason: CGMP Deviation; cotton coil is missing in some packaged bottles

Code information: NDC 0093-5035-01, Lot numbers 14064211A, exp 3/2014; 14064311A, exp 3/2014; 14064411A, exp 3/2014; 14064511A, exp 3/2014; 14090312A, exp 4/2015; 14092512A, exp 4/2015; 14092712A, exp 4/2015; 14094612A, exp 4/2015; 14099412A, exp 4/2015; 14099612B, exp 4/2015; 14099712A, exp 5/2015; 14110111A, exp 5/2014; 14110211A, exp 5/2014; 14110311A, exp 5/2014; 14110411A, exp 5/2014 and 34090212A, exp 4/2015.

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation