Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
662 recalls in this category, newest first.
Reason Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Reason Presence of precipitate
Reason Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Reason Lack of Process Controls
Reason Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Reason Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability…
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Reason CGMP Deviations
Reason Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Reason Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Reason Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Reason Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Reason Failed Impurities/Degradation Specifications.
Reason Failed Impurities/Degradation Specifications.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Reason Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
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