Why it was recalled
Subpotent
Product description
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.
Lot numbers, UPCs & expiration codes
Service Code 2K2466 and 2K2470 183320004S, 183330008S, 183340002S, 183340003S, 183300004S, 183310007S, 183370041S, 183310043S, 183370042S, 183320003S, 183380007S, 183250013S, 183250014S, 183320005S, 183330009S, 183370007S, 183390044S, 183400006S, 183410003S.
Where it was sold
Product was distributed throughout the 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-0374-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 2, 2019
- FDA report date
- Jan 16, 2019
- Quantity
- 7,711 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PharMEDium Services, LLC.
Original FDA data
Every field from FDA enforcement report D-0374-2019, exactly as published.
Show all FDA fields
- City
- Cleveland
- State
- MS
- Status
- Terminated
- Country
- United States
- Event ID
- 81895
- Address
- 913 N Davis Ave
- Code information
- Service Code 2K2466 and 2K2470 183320004S, 183330008S, 183340002S, 183340003S, 183300004S, 183310007S, 183370041S, 183310043S, 183370042S, 183320003S, 183380007S, 183250013S, 183250014S, 183320005S, 183330009S, 183370007S, 183390044S, 183400006S, 183410003S.
- Postal code
- 38732-2106
- Report date
- Jan 16, 2019
- Product type
- Drugs
- Recall number
- D-0374-2019
- Classification
- Class II
- Recalling firm
- PharMEDium Services, LLC.
- Product quantity
- 7,711 syringes
- Termination date
- May 7, 2020
- Reason for recall
- Subpotent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Jan 2, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 14, 2019