Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
Compare with the code on your package — it is the most precise check available.
Drug: Pyridostigmine
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pyridostigmine Bromide NDC 66689-0406 |
60 mg/5mL | Solution Oral |
VistaPharm, LLC | Rx |
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.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Failed Excipient Specifications: high content of ethylene glycol (EG)
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
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