Why it was recalled
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Product description
Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834
Lot numbers, UPCs & expiration codes
Lot: 41179A Exp. Jan 2023
Where it was sold
Nationwide in the US Market
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-1152-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 9, 2022
- FDA report date
- Jun 29, 2022
- Quantity
- 1440 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mayne Pharma Inc
Original FDA data
Every field from FDA enforcement report D-1152-2022, exactly as published.
Show all FDA fields
- City
- Greenville
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 90406
- Address
- 1240 Sugg Pkwy
- Code information
- Lot: 41179A Exp. Jan 2023
- Postal code
- 27834-9006
- Report date
- Jun 29, 2022
- Product type
- Drugs
- Recall number
- D-1152-2022
- Classification
- Class II
- Recalling firm
- Mayne Pharma Inc
- Product quantity
- 1440 cartons
- Termination date
- Aug 23, 2023
- Reason for recall
- Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834
- Distribution pattern
- Nationwide in the US Market
- Recall initiation date
- Jun 9, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 21, 2022