Class II · Moderate risk Ongoing
Erythromycin Tablets
Reason CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Erythromycin Topical Gel USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
What was recalled
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.
- Recalling firm
- Teligent Pharma, Inc.
- NDC code
- 63739-053-66
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0716-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Erythromycin recalls
See all
Class II · Moderate risk Ongoing
Erythromycin Tablets
Reason CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Erythromycin Ophthalmic Ointment USP
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Erythromycin Ophthalmic Ointment USP 0.5%
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Erythromycin Topical Gel USP
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
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