Recalls of common over-the-counter and prescription pain relievers.
415 recalls in this category, newest first.
Reason CGMP Deviations: Released product should have been rejected.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason Failed Tablet/Capsule Specifications
Reason Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Reason Failed Impurities/Degradation Specifications - at 18-month Stability testing
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…
Reason Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Reason Label mix-up: Carton incorrectly labeled.
Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Reason Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection…
Reason Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81…
Reason Discoloration: Brownish tablets
Reason Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count…
Reason Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL…
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL…
Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Reason Microbial Contamination of Non-Sterile Products
Reason Microbial Contamination of Non-Sterile Products
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Reason Defective Delivery System
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