Class II · Moderate risk Ongoing
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP…
Reason CGMP Deviations:Noted during FDA inspection
Is Sildenafil recalled?
10 FDA recalls mention Sildenafil. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sildenafil.
Class II · Moderate risk Ongoing
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP…
Reason CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk Terminated
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
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, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
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.
Class II · Moderate risk Terminated
Sildenafil 200 mg Troche (Clinic)
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class II · Moderate risk Terminated
Sildenafil 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Class II · Moderate risk Terminated
Sildenafil Citrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
SILDENAFIL CITRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069420030.
Reason Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/…
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