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 Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the…
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Failed pH specification
Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to…
Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to…
Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to…
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Reason CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Reason Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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 Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be…
Reason Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
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