Why it was recalled
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Product description
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
Lot numbers, UPCs & expiration codes
Lot #: UP1103, Exp 04/2016; UQ1001, Exp 04/2017
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0571-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 15, 2015
- FDA report date
- Jan 27, 2016
- Quantity
- 39,187 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0571-2016, exactly as published.
Show all FDA fields
- City
- Morton Grove
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72876
- Address
- 6451 Main St
- Code information
- Lot #: UP1103, Exp 04/2016; UQ1001, Exp 04/2017
- Postal code
- 60053-2633
- Report date
- Jan 27, 2016
- Product type
- Drugs
- Recall number
- D-0571-2016
- Classification
- Class III
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Product quantity
- 39,187 bottles
- Termination date
- Sep 13, 2016
- Reason for recall
- Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 15, 2015
- Initial firm notification
- Letter
- Center classification date
- Jan 15, 2016