Why it was recalled
Presence of Particulate Matter: One vial was found to contain a hair.
Product description
Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05
Lot numbers, UPCs & expiration codes
Lot #: CLC180117, Exp. June 2021
Where it was sold
Product is being held at a distributor site in Mexico, Asheboro, NC, Charlotte, NC and Santa Teresa, NM and not further distributed in the U.S. Market.
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-1248-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 28, 2019
- FDA report date
- Apr 17, 2019
- Quantity
- 88600 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-1248-2019, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82496
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: CLC180117, Exp. June 2021
- Postal code
- 08520-1401
- Report date
- Apr 17, 2019
- Product type
- Drugs
- Recall number
- D-1248-2019
- Classification
- Class I
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 88600 vials
- Termination date
- Apr 11, 2024
- Reason for recall
- Presence of Particulate Matter: One vial was found to contain a hair.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05
- Distribution pattern
- Product is being held at a distributor site in Mexico, Asheboro, NC, Charlotte, NC and Santa Teresa, NM and not further distributed in the U.S. Market.
- Recall initiation date
- Mar 28, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2019