Why it was recalled
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Product description
Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.
Lot numbers, UPCs & expiration codes
Lot: 15724, Exp. 06/2022
Where it was sold
Nationwide in the USA.
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-0716-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2022
- FDA report date
- Feb 23, 2022
- Quantity
- 11040 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0716-2022, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89560
- Address
- 105 Lincoln Avenue
- Code information
- Lot: 15724, Exp. 06/2022
- Postal code
- 08310
- Report date
- Feb 23, 2022
- Product type
- Drugs
- Recall number
- D-0716-2022
- Classification
- Class II
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 11040 tubes
- Termination date
- May 9, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 24, 2022