Why it was recalled
Defective container: possibility for lack of seal integrity.
Product description
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
Lot numbers, UPCs & expiration codes
Lot #: 14892, Exp 1/2022
Where it was sold
USA 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-0769-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 29, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 7488 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0769-2021, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 88377
- Address
- 105 Lincoln Avenue
- Code information
- Lot #: 14892, Exp 1/2022
- Postal code
- 08310
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0769-2021
- Classification
- Class II
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 7488 bottles
- Reason for recall
- Defective container: possibility for lack of seal integrity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 25, 2021