Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Failed Stability Specifications
sulfur8
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids, spray, Active Ingredient: Salicylic Acid, 2%, 12 FL OZ (356ml) spray bottle, OTC, Made in the U.S.A. J. Strickland & Co., OLIVE BRANCH, MS 38654 UPC: 0 7561044510 7
Drug: Sulfur
- Recalling firm
- J. Strickland and Co
- Origin
- MS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0318-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Sulfur recalls
See all
Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Class II · Moderate risk
Albuterol (Pf/Sulfuric Acid/Dye Free)
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class II · Moderate risk
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by J. Strickland and Co
All 2014 recalls
Class III · Low risk
sulfur8 medicated LIGHT FORMULA
Subpotent Drug: failed at the 3 and 6 month stability time points.
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