Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma…
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
1,061 FDA recalls mention East. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of East.
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
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 CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Reason Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream…
Reason Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability…
Reason Lack of assurance of sterility.
Reason Lack of assurance of sterility.
Reason Lack of assurance of sterility.
Reason Lack of assurance of sterility.
Reason Lack of assurance of sterility.
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