Why it was recalled
Superpotent Drug
Product description
Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.
Lot numbers, UPCs & expiration codes
Lot #:14218, Exp. Date 08/2022
Where it was sold
Nationwide within the United States and Canada
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-0800-2021
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 3, 2021
- FDA report date
- Sep 22, 2021
- Quantity
- 32,544 glass bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0800-2021, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 88454
- Address
- 105 Lincoln Avenue
- Code information
- Lot #:14218, Exp. Date 08/2022
- Postal code
- 08310
- Report date
- Sep 22, 2021
- Product type
- Drugs
- Recall number
- D-0800-2021
- Classification
- Class I
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 32,544 glass bottles
- Reason for recall
- Superpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.
- Distribution pattern
- Nationwide within the United States and Canada
- Recall initiation date
- Aug 3, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2021