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Class III · Low risk Terminated Initiated Jun 13, 2018 (8 years ago)

Equate ClearLAX

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

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

Affected NDCs 49035-0312-07 49035-0312-08

Compare with the code on your package — it is the most precise check available.

Recalling firm
Lupin Somerset
NDC code
49035-312-07
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0907-2018 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Lupin Somerset

All 2018 recalls

Other labeling / mix-up recalls from 2018

All labeling / mix-up recalls
Class III · Low risk

Loperamide HCL Tablets USP

Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

Terminated Labeling / mix-up Sun Pharmaceutical Industries, Inc. D-0391-2019
Class I · High risk

Dyural-80 Injection Kit

Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex

Terminated Labeling / mix-up Asclemed USA Inc. dba Enovachem NDC 76420-0755-01 D-0354-2019
Class I · High risk

Dyural-40 Injection Kit

Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex

Terminated Labeling / mix-up Asclemed USA Inc. dba Enovachem NDC 76420-0750-01 D-0353-2019