68 FDA recalls mention Ibuprofen. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ibuprofen.
Reason Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Reason CGMP Deviations
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 Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Reason Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
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