Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
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.
VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,
Compare with the code on your package — it is the most precise check available.
Drug: Ethambutol
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.
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Failed Impurities/Degradation Specifications; 12 month stability testing.
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
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