Why it was recalled
Presence of Foreign Substance: Foreign material found inside the vial.
Product description
Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.
Lot numbers, UPCs & expiration codes
Batch #: CLC190049, Exp 02/2022
Where it was sold
Nationwide in the USA
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-0573-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 11, 2019
- FDA report date
- Dec 4, 2019
- Quantity
- 111,850 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0573-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84241
- Address
- 279 Princeton Hightstown Rd
- Code information
- Batch #: CLC190049, Exp 02/2022
- Postal code
- 08520-1401
- Report date
- Dec 4, 2019
- Product type
- Drugs
- Recall number
- D-0573-2020
- Classification
- Class II
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 111,850 vials
- Termination date
- Nov 17, 2020
- Reason for recall
- Presence of Foreign Substance: Foreign material found inside the vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 5, 2019