Recalls of common over-the-counter and prescription pain relievers.
415 recalls in this category, newest first.
Reason Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Reason Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Reason Presence of Foreign Substance: foreign material found in the bulk inventory.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason cGMP deviations - presence of rubber particles found loose in the bulk product.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Presence of Particulate Matter
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations
Reason Labeling: Not elsewhere classified - count on the label was incorrect.
Reason Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Reason Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Reason Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Reason Failed Dissolution Specifications
Reason Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the…
Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the…
Reason Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the…
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
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