Skip to content
Recall Observatory FDA recall evidence

Drug product

Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716

D-0907-2018

June 13, 2018

Class III

Product summary

Firm
LUPIN SOMERSET
Event
Event 80266
Status
Terminated
Classification
Class III
Quantity
2,229,052 bottles
Official record key
drug-enforcement:D-0907-2018

Official wording

Reason: Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.

Code information: a) M16425A, Exp 06/18; M16463A, Exp 7/18; M16516A, Exp 8/19; M16605A, Exp 10/19; M17005A, Exp 1/20; S700119, S700157, Exp 3/20; S700228, Exp 4/20; S700304, Exp 5/20; S700510, Exp 7/20; S700780, Exp 10/20; S701063, S701112, Exp 12/20; S800170, Exp 2/21; S800349, Exp 3/21; S800366, Exp 4/21; S800453, Exp 5/21; b) M16560A, M16561A, M16562A, Exp 9/19; M16607A, Exp 11/19; S700202, Exp 4/20; S700415, Exp 6/20; S700511, Exp 7/20; S700752, Exp 9/20; S700902, Exp 10/20; S701119, Exp 12/20; S800097, Exp 2/21; S800296, S800306, Exp 3/21.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.

Field note

Send feedback

We'll only use this to respond to your feedback.