Eye Drops & Ophthalmic Recalls

Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.

662 recalls in this category, newest first.

Class II · Moderate risk Terminated May 21, 2012

PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 ML (1 PRODUCT)

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1600-2012

Class II · Moderate risk Terminated May 21, 2012

PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE 1 ML 10…

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1599-2012

Class II · Moderate risk Terminated May 21, 2012

MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML; MITOMYCIN SOLUTION…

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1581-2012

Class II · Moderate risk Terminated May 21, 2012

LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT)

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1564-2012

Class II · Moderate risk Terminated May 21, 2012

LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML 400 ML (7 DIFFERENT…

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1563-2012

Class II · Moderate risk Terminated May 21, 2012

LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.00025%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML…

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1561-2012

Class II · Moderate risk Terminated May 21, 2012

LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE 24 ML 6 ML; LIDOCAINE…

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1560-2012

Class II · Moderate risk Terminated May 21, 2012

LIDOCAINE HCL/BUPIVACAINE HCL PF 1%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE…

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1559-2012

Class II · Moderate risk Terminated May 21, 2012

LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML 500 ML …

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1558-2012

Class II · Moderate risk Terminated Apr 30, 2012

Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile…

Reason Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.

Apotex Inc. D-1439-2012

Class II · Moderate risk Terminated Mar 1, 2010

Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic…

Reason Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list…

K C Pharmaceuticals Inc D-192-2013

Class I · High risk Terminated Feb 24, 2006

Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.

Reason Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.

Merit Medical Systems, Inc NDC 23731-8100-8 D-040-2013

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