Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India…
Reason CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
14 FDA recalls mention Erythromycin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Erythromycin.
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 CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability…
Reason Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Reason Defective container: possibility for lack of seal integrity.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Reason Labeling: Label Mixup; ERYTHROMYCIN DR EC Tablet, 250 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 00781502201…
Reason Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
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