Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged...
FDA Drug Recall #D-0907-2018 — Class III — June 13, 2018
Recall Summary
| Recall Number | D-0907-2018 |
| Classification | Class III — Low risk |
| Date Initiated | June 13, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | LUPIN SOMERSET |
| Location | Somerset, NJ |
| Product Type | Drugs |
| Quantity | 2,229,052 bottles |
Product Description
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
Reason for Recall
Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
Distribution Pattern
Nationwide
Lot / 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.
Other Recalls from LUPIN SOMERSET
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1244-2019 | Class III | Morphine Sulfate Extended-Release Tablets, 30 m... | Apr 10, 2019 |
| D-1247-2019 | Class III | Morphine Sulfate Extended-Release Tablets, 200 ... | Apr 10, 2019 |
| D-1243-2019 | Class III | Morphine Sulfate Extended-Release Tablets, 15 m... | Apr 10, 2019 |
| D-1246-2019 | Class III | Morphine Sulfate Extended-Release Tablets, 100 ... | Apr 10, 2019 |
| D-1245-2019 | Class III | Morphine Sulfate Extended-Release Tablets, 60 m... | Apr 10, 2019 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.