Why it was recalled
Superpotent and Subpotent; low and high assay results
Product description
Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
Lot numbers, UPCs & expiration codes
Lot Number: 12597, exp. date 12/2020
Where it was sold
Nationwide
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-0119-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 5, 2020
- FDA report date
- Dec 9, 2020
- Quantity
- 20160 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0119-2021, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86714
- Address
- 105 Lincoln Avenue
- Code information
- Lot Number: 12597, exp. date 12/2020
- Postal code
- 08310
- Report date
- Dec 9, 2020
- Product type
- Drugs
- Recall number
- D-0119-2021
- Classification
- Class III
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 20160 tubes
- Termination date
- Aug 16, 2024
- Reason for recall
- Superpotent and Subpotent; low and high assay results
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 5, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 8, 2020