Why it was recalled
Defective Container
Product description
Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05
Lot numbers, UPCs & expiration codes
Lot #: 15188, Exp 2/2023
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-0258-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 19, 2021
- FDA report date
- Dec 1, 2021
- Quantity
- 2664 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0258-2022, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88884
- Address
- 105 Lincoln Avenue
- Code information
- Lot #: 15188, Exp 2/2023
- Postal code
- 08310
- Report date
- Dec 1, 2021
- Product type
- Drugs
- Recall number
- D-0258-2022
- Classification
- Class II
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 2664 bottles
- Termination date
- Jun 18, 2024
- Reason for recall
- Defective Container
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 19, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 23, 2021