Why it was recalled
Superpotent Drug
Product description
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
Lot numbers, UPCs & expiration codes
Lot #: 16345, Exp. Date 01/2024
Where it was sold
Distributed to a wholesaler in CO who further distributed 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-0295-2022
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Nov 30, 2021
- FDA report date
- Jan 5, 2022
- Quantity
- 6,816 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0295-2022, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 89135
- Address
- 105 Lincoln Avenue
- Code information
- Lot #: 16345, Exp. Date 01/2024
- Postal code
- 08310
- Report date
- Jan 5, 2022
- Product type
- Drugs
- Recall number
- D-0295-2022
- Classification
- Class I
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 6,816 bottles
- Reason for recall
- Superpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
- Distribution pattern
- Distributed to a wholesaler in CO who further distributed Nationwide in the USA
- Recall initiation date
- Nov 30, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 28, 2021