Why it was recalled
Failed Stability Specifications
Product description
Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
Lot numbers, UPCs & expiration codes
Carton Lot Number:1147020B Patch (Envelope) Lot Number: 1147020
Where it was sold
United States
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-0857-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 30, 2018
- FDA report date
- May 30, 2018
- Quantity
- 30,382 patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0857-2018, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 80004
- Address
- 1090 Horsham Rd
- Code information
- Carton Lot Number:1147020B Patch (Envelope) Lot Number: 1147020
- Postal code
- 19454-1505
- Report date
- May 30, 2018
- Product type
- Drugs
- Recall number
- D-0857-2018
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 30,382 patches
- Termination date
- Jan 14, 2019
- Reason for recall
- Failed Stability Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
- Distribution pattern
- United States
- Recall initiation date
- Apr 30, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 11, 2018