Class II · Moderate risk
B-Complex
Presence of Particulate Matter.
Riboflavin 5-Phosphate Sodium Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.
Affected NDC
69623-0106-61
Compare with the code on your package — it is the most precise check available.
Drug: Riboflavin Category: Eye Drops & Ophthalmic
- Recalling firm
- Premier Pharmacy Labs Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1425-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Riboflavin recalls
See all
Class II · Moderate risk
Thiamine/Ribofla/Niacinami/Dexpanth/Pyridox/Hydroxycobal 25mg/25mg/25mg/25mg/25mg/20mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Thiamine Hydrochloride 3000 mg/30 mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk
Thiamine Hydrochloride 200 mg/2mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk
B-Complex + Chromic Chloride
Lack of Assurance of Sterility
Other recalls by Premier Pharmacy Labs Inc
All 2019 recalls
Class II · Moderate risk
SUCCINYLcholine Chloride
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
SUCCINYLcholine Chloride
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Sodium Bicarbonate INJ 8.4%
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Phenylephrine HCL PF INJ in 0.9% Sodium Chloride
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
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