Class II · Moderate risk Ongoing
Sildenafil Citrate USP
Reason CGMP Deviations:Noted during FDA inspection
Sildenafil Citrate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, NDC 66213042510, Pedigree: W003640, EXP: 6/25/2014.
What was recalled
SILDENAFIL CITRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069420030.
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-804-2014
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.
Other Sildenafil recalls
See all
Class II · Moderate risk Ongoing
Sildenafil Citrate USP
Reason CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk Terminated
Sildenafil Tablets USP 100 mg
Reason Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class II · Moderate risk Terminated
Sildenafil 50 mg Troche
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Sildenafil 80 mg capsules
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
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