Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
100 FDA recalls mention Ranitidine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ranitidine.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Reason Failed Stability Specifications
Reason Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Reason Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Reason Lack of sterility assurance.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP…
Reason Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Reason Failed Impurity/Degradation Specification; "Related Compound C"
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
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