Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13…
Reason Lack of Assurance of Sterility
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
What was recalled
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
- Recalling firm
- Shiseido America INC.
- NDC code
- 98132-761-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0214-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road…
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Class II · Moderate risk Ongoing
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Reason CGMP Deviations; deficiencies observed during FDA inspection
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