Why it was recalled
Non-Sterility: failed sterility test result.
Product description
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Lot numbers, UPCs & expiration codes
Lot #: 50699:00, Exp 10/04/16
Where it was sold
Two medical facilities in TX
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-0211-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 23, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 180 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Guardian Pharmacy Services
Original FDA data
Every field from FDA enforcement report D-0211-2017, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 75268
- Address
- 7920 Elmbrook Dr Ste 108
- Code information
- Lot #: 50699:00, Exp 10/04/16
- Postal code
- 75247-4933
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0211-2017
- Classification
- Class I
- Recalling firm
- Guardian Pharmacy Services
- Product quantity
- 180 syringes
- Termination date
- Aug 7, 2017
- Reason for recall
- Non-Sterility: failed sterility test result.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
- Distribution pattern
- Two medical facilities in TX
- Recall initiation date
- Sep 23, 2016
- Initial firm notification
- Telephone
- Center classification date
- Dec 22, 2016