STELLALIFE ADVANCED FORMULA Peppermint
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02
Compare with the code on your package — it is the most precise check available.
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.
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
cGMP deviations
cGMP deviations
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
cGMP Deviations
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
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