Recalls of acid reducers and stomach drugs - the class behind the ranitidine (Zantac) nitrosamine recalls.
209 recalls in this category, newest first.
Reason Failed Tablet/Capsule Specification: out of specification for tablet weight.
Reason Failed Tablet/Capsule Specification; out of specification for tablet weight
Reason CGMP Deviations
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Reason Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Reason Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per…
Reason Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per…
Reason Microbial Contamination of Non-Sterile Product
Reason Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab…
Reason CGMP Deviations
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradation Specifications; 12 month stability time point
Reason Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Reason Lack of Assurance of Sterility
Reason Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Reason Stability data does not support expiry.
Reason Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.