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