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Penicillin Cross Contamination
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Lack of Assurance of Sterility: All compounded products.
The product was produced using bulk L-Citrulline lot # 121109 which was subsequently recalled by the supplier since the lot was found to contain a compound other than L-Citrulline.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.
The dietary supplement lot contains Chloramphenicol at a level of 9.7 ppb.
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.