Class II · Moderate risk
Erythromycin Tablets
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
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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
Affected NDC
63739-0053-68
Compare with the code on your package — it is the most precise check available.
Drug: Erythromycin
- Recalling firm
- McKesson Corporation dba McKesson Drug Company
- NDC code
- 63739-053-68
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0851-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Erythromycin recalls
See all
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Erythromycin Ophthalmic Ointment USP
CGMP Deviations:
Class II · Moderate risk
Erythromycin Ophthalmic Ointment USP 0.5%
CGMP Deviations:
Class II · Moderate risk
Erythromycin Topical Gel USP
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Other recalls by McKesson Corporation dba McKesson Drug Company
All 2022 recalls
Class II · Moderate risk
Gemcitabine Injection
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Class I · High risk
Udenyca
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Class II · Moderate risk
Inflectra (infliximab-dyyb)
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Class II · Moderate risk
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide)
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
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