Leiter's Compounding Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in recall — FDA D-0013-2017
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.