Why it was recalled
CGMP Deviations: not manufactured according to current good manufacturing practices.
Product description
BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
Lot numbers, UPCs & expiration codes
Lot: 17JXIII, Exp. 12/31/2019
Where it was sold
NY
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-0421-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 7, 2018
- FDA report date
- Feb 21, 2018
- Quantity
- 1 bottle
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Webrx dba RxPalace.com
Original FDA data
Every field from FDA enforcement report D-0421-2018, exactly as published.
Show all FDA fields
- City
- Sarasota
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 79172
- Address
- 501 N Beneva Rd Ste 550
- Code information
- Lot: 17JXIII, Exp. 12/31/2019
- Postal code
- 34232-1352
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0421-2018
- Classification
- Class III
- Recalling firm
- Webrx dba RxPalace.com
- Product quantity
- 1 bottle
- Termination date
- May 19, 2020
- Reason for recall
- CGMP Deviations: not manufactured according to current good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
- Distribution pattern
- NY
- Recall initiation date
- Feb 7, 2018
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 14, 2018