Class II · Moderate risk
Vardenafil 20 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Vardenafil HCl
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
Affected NDC
60592-0330-05
Compare with the code on your package — it is the most precise check available.
Drug: Vardenafil
- Recalling firm
- Kalchem International, Inc.
- NDC code
- 60592-330-05
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0582-2018 · FDA notice
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.
Other Vardenafil recalls
See all
Class II · Moderate risk
Vardenafil HCl USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Vardenafil HCl Trihydrate active pharmaceutical ingredient…
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.
Other stability / shelf life recalls from 2018
All stability / shelf life recalls
Class III · Low risk
COSOPT Ophthalmic Solution
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Class II · Moderate risk
INFed (Iron Dextran Injection USP)
Failed Stability Specification: out of specification for iron content.
Class III · Low risk
Megestrol Acetate Oral Suspension
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Cream
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
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