Class II · Moderate risk Terminated
Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX…
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS 100 mL Accuflo, Rx Only, Compounded by Option Care…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d) 1.5G/NS 250 mL e)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d)…
Reason Presence of Foreign Substance
Class II · Moderate risk Terminated
Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods…
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk Terminated
Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite…
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk Terminated
Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100…
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk Terminated
Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy…
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk Terminated
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American…
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page…
Reason Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states…
Class II · Moderate risk Terminated
Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC…
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk Terminated
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount…
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk Terminated
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144…
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk Terminated
Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For…
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk Terminated
Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Reason Lack of Assurance of Sterility