Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-83...
FDA Drug Recall #D-0571-2016 - Class III, December 15, 2015
Recall Summary
| Recall Number | D-0571-2016 |
| Classification | Class III, Low risk |
| Date Initiated | December 15, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Morton Grove Pharmaceuticals, Inc. |
| Location | Morton Grove, IL |
| Product Type | Drugs |
| Quantity | 39,187 bottles |
Product Description
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
Reason for Recall
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Distribution Pattern
Nationwide and Puerto Rico
Lot / Code Information
Lot #: UP1103, Exp 04/2016; UQ1001, Exp 04/2017
Other Recalls from Morton Grove Pharmaceuticals, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0713-2022 | Class II | Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 f... | Feb 21, 2022 |
| D-0815-2021 | Class II | Promethazine With Codeine Oral Solution, (Prome... | Sep 3, 2021 |
| D-0816-2021 | Class II | Valproic Acid Oral Solution USP, (250 mg/5 mL)... | Sep 3, 2021 |
| D-0814-2021 | Class II | Promethazine Syrup Plain, 6.25 mg/5 mL (Prometh... | Sep 3, 2021 |
| D-0174-2021 | Class II | Hydroxyzine Hydrochloride Oral Solution, USP (S... | Dec 9, 2020 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping, abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects 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.