Product Recalls in 2015 - All Sources

FDA Drug Class II Terminated

Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64

September 12, 2015 US Compounding Inc 494 syringes units

FDA Drug Class II Terminated

HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99

September 12, 2015 US Compounding Inc 7,852 vials units

FDA Drug Class II Terminated

Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03.

September 12, 2015 US Compounding Inc 862 bottles units

FDA Drug Class II Terminated

Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02

September 12, 2015 US Compounding Inc 235 vials units

FDA Drug Class II Terminated

Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.

September 12, 2015 US Compounding Inc 265 vials units

FDA Drug Class II Terminated

Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC

September 12, 2015 US Compounding Inc 103 vials units

FDA Drug Class II Terminated

Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3082-05

September 12, 2015 US Compounding Inc 14,325 syringes units

FDA Drug Class II Terminated

Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3104-07

September 12, 2015 US Compounding Inc 1,421 vials units

FDA Drug Class II Terminated

L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01

September 12, 2015 US Compounding Inc 1,706 vials units

FDA Drug Class II Terminated

Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01

September 12, 2015 US Compounding Inc 33,778 vials units

FDA Drug Class II Terminated

ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.

September 12, 2015 US Compounding Inc 3 dropper bottles units

FDA Drug Class II Terminated

Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99

September 12, 2015 US Compounding Inc 2,984 bottles units

FDA Drug Class II Terminated

Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02

September 12, 2015 US Compounding Inc 6,008 vials units

FDA Drug Class II Terminated

Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06

September 12, 2015 US Compounding Inc 13,843 vials units

FDA Drug Class II Terminated

Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05

September 12, 2015 US Compounding Inc 11 vials units

FDA Drug Class II Terminated

Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10

September 12, 2015 US Compounding Inc 2 dropper bottles units

FDA Drug Class II Terminated

Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial

September 12, 2015 US Compounding Inc 1,093 vials units

FDA Drug Class II Terminated

Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07

September 12, 2015 US Compounding Inc 14,580 vials units

FDA Drug Class II Terminated

Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653

September 12, 2015 US Compounding Inc 1 bottle units

FDA Drug Class II Terminated

Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02

September 12, 2015 US Compounding Inc 5,514 vials units

FDA Drug Class II Terminated

Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07

September 12, 2015 US Compounding Inc 1,198 bottles units

FDA Drug Class II Terminated

MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3113-07

September 12, 2015 US Compounding Inc 439 vials units

FDA Drug Class II Terminated

Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01

September 12, 2015 US Compounding Inc 1,096 vials units

FDA Drug Class II Terminated

Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06

September 12, 2015 US Compounding Inc 1,386 vials units

FDA Drug Class II Terminated

Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0002-50

September 12, 2015 US Compounding Inc 711 syringes units

FDA Drug Class II Terminated

MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3119-01.

September 12, 2015 US Compounding Inc 22,627 vials units

FDA Drug Class II Terminated

Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07

September 12, 2015 US Compounding Inc 7,320 syringes units

FDA Drug Class II Terminated

Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02

September 12, 2015 US Compounding Inc 4,333 vials units

FDA Drug Class II Terminated

Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3155-01

September 12, 2015 US Compounding Inc 542 vials units

FDA Drug Class II Terminated

MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL), 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Phar

September 12, 2015 US Compounding Inc 1,939 vials units

FDA Drug Class II Terminated

MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.

September 12, 2015 US Compounding Inc 1,736 vials units

FDA Drug Class II Terminated

Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3122-07

September 12, 2015 US Compounding Inc 11,363 vials units

FDA Drug Class II Terminated

Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02

September 12, 2015 US Compounding Inc 820 bottles units

FDA Drug Class II Terminated

Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07

September 12, 2015 US Compounding Inc 2,524 vials units

FDA Drug Class II Terminated

Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01

September 12, 2015 US Compounding Inc 105 syringes units

FDA Drug Class II Terminated

MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07

September 12, 2015 US Compounding Inc 3,629 vials units

FDA Drug Class II Terminated

Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06

September 12, 2015 US Compounding Inc 55 vials units

FDA Drug Class II Terminated

Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3226-07

September 12, 2015 US Compounding Inc 562 vials units

FDA Food Class III Terminated

Iowa Select Herbs LLC, Goldenseal Root (Hydrastis canadensis), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 32 fl. Oz. (c) 1 gallon, Cedar Rapids, IA 52402

September 11, 2015 Iowa Select Herbs LLC (a) 1 bottle, (b) 1 bottle, (c) 1 bottle units

FDA Food Class III Terminated

Iowa Select Herbs LLC, Suma Root, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402

September 11, 2015 Iowa Select Herbs LLC 3 bottles units

FDA Food Class III Terminated