Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Erythromycin Topical Gel USP, 2%, Net Wt 60 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 63739-053-68
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.
Reason CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Reason CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Reason CGMP Deviations:
Reason CGMP Deviations:
Reason Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
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