DL DrugLabelsHubFDA Drug Label Lookup

FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP Meta Pharmacy Services Class II Terminated 20161228
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01 Amgen, Inc. Class II Terminated 20161228
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950 Les Emballages Knowlton Inc. Class III Terminated 20161228
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02 Inventia Healthcare Private Limited Class II Terminated 20161228
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle Love My Tru Body Class I Terminated 20161228
3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. Making It a Lifestyle Class II Terminated 20161228
BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. Making It a Lifestyle Class I Terminated 20161228
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. Making It a Lifestyle Class I Terminated 20161228
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR US Compounding Inc Class I Terminated 20161228
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02 Hospira Inc., A Pfizer Company Class I Ongoing 20161228
GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15 Novo Nordisk Inc Class I Terminated 20161228
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818 Sperian Eye & Face Protection, Inc Class I Terminated 20161228
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA Impax Laboratories, Inc. Class I Terminated 20161228
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10. VIRTUS PHARMACEUTICALS OPCO II L Class I Terminated 20161228
Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10. VIRTUS PHARMACEUTICALS OPCO II L Class I Terminated 20161228
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10. VIRTUS PHARMACEUTICALS OPCO II L Class I Terminated 20161228
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only Guardian Pharmacy Services Class I Terminated 20161228
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007. Ultimate Body Tox Class I Terminated 20161228
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067 Colonia Care Pharmacy Class II Terminated 20161228
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067 Colonia Care Pharmacy Class II Terminated 20161228
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Zydus Pharmaceuticals USA Inc Class III Terminated 20161228
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48. Baxter Healthcare Corporation Class II Terminated 20161228
Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14. Jubilant Cadista Pharmaceuticals, Inc. Class III Terminated 20161221
Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12 Cantrell Drug Company Class II Terminated 20161221
Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-185-75 Cantrell Drug Company Class II Terminated 20161221
Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15 Cantrell Drug Company Class II Terminated 20161221
Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-056-30 Cantrell Drug Company Class II Terminated 20161221
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15 Cantrell Drug Company Class II Terminated 20161221
Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-160-75 Cantrell Drug Company Class II Terminated 20161221
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-001-04 Cantrell Drug Company Class II Terminated 20161221
Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207 Cantrell Drug Company Class II Terminated 20161221
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-10 Cantrell Drug Company Class II Terminated 20161221
HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04 Cantrell Drug Company Class II Terminated 20161221
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03 Cantrell Drug Company Class II Terminated 20161221
Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24 Cantrell Drug Company Class II Terminated 20161221
Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-148-16 Cantrell Drug Company Class II Terminated 20161221
Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15 Cantrell Drug Company Class II Terminated 20161221
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75 Cantrell Drug Company Class II Terminated 20161221
Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-61 Cantrell Drug Company Class II Terminated 20161221
Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-35 Cantrell Drug Company Class II Terminated 20161221
Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207 Cantrell Drug Company Class II Terminated 20161221
Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Single-Dose Bag Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-102-09 Cantrell Drug Company Class II Terminated 20161221
Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-171-12 Cantrell Drug Company Class II Terminated 20161221
Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37 Cantrell Drug Company Class II Terminated 20161221
USCG Boat Response Kit - Product Code 80-0353, North American Rescue North American Rescue LLC. Class II Terminated 20161214
Aid Backpack Kit - Product Code 85-0917, North American Rescue North American Rescue LLC. Class II Terminated 20161214
Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue North American Rescue LLC. Class II Terminated 20161214
Amphibious Trauma Kit - Product Code 85-0639, North American Rescue North American Rescue LLC. Class II Terminated 20161214
K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue North American Rescue LLC. Class II Terminated 20161214
Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue North American Rescue LLC. Class II Terminated 20161214