Yes — there is an active recall. 62 ongoing FDA recalls mention Methyl (501 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Methyl. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Reason Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with…
Reason Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with…
Reason Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to…
Reason Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to…
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the…
Reason Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of…
Reason Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was…
Reason Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Reason Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as the following drug: OMEPRAZOLE/SODIUM BICARBONATE…
Reason Labeling:Label Mixup; methylPREDNISolone Tablet, 4 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 137 mcg, NDC 00781519192…
Reason Labeling: Label Mixup; METHYLERGONOVINE MALEATE Tablet, 0.2 mg may be potentially mislabeled as ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC…
Reason Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM…
Reason Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability…
Reason Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability…
Reason Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability…
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
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