openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Code information
Lot #: 05082014@7, Exp 11/04/2014
Distribution pattern
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
drug · product 2 of 4
Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Code information
Lot #: 05122014@4, Exp 09/09/2014
Distribution pattern
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Code information
Lot #: 05202014@7, Exp 11/19/2014
Distribution pattern
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
drug · product 4 of 4
Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Code information
Lot #: 05202014@3, Exp 11/16/2014
Distribution pattern
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
