Why it was recalled
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Product description
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
Lot numbers, UPCs & expiration codes
Lot #: 13058, Exp. date 02/2022 and 13768, Exp. date 05/2022
Where it was sold
Nationwide within 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-0281-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 12, 2021
- FDA report date
- Dec 22, 2021
- Quantity
- 14,664 glass bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0281-2022, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88850
- Address
- 105 Lincoln Avenue
- Code information
- Lot #: 13058, Exp. date 02/2022 and 13768, Exp. date 05/2022
- Postal code
- 08310
- Report date
- Dec 22, 2021
- Product type
- Drugs
- Recall number
- D-0281-2022
- Classification
- Class II
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 14,664 glass bottles
- Termination date
- Jun 18, 2024
- Reason for recall
- CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 12, 2021
- Initial firm notification
- Press Release
- Center classification date
- Dec 13, 2021