Class I — High risk. Reasonable probability of serious harm or death.
Microbial contamination
NET Remedies #8 (Royal Blue Label) Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc. U.S.A. Supplier: NET (Australia) Pty LTD 428 Hume Street, Toowoomba QLD 4350, Australia
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.
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Reason Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
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