FDA Recall
Terminated
Historical recordClass II
Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01.
by Genentech Inc.
- Reason
- Superpotent Drug: An oversized tablet was found in a bottle.
- Published
- April 12, 2017
- Distribution
- NJ and IL
View recall →
FDA Recall
Terminated
Historical recordClass III
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
by Fresenius Kabi USA, LLC
- Reason
- Subpotent Drug
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
by Hospira Inc., A Pfizer Company
- Reason
- Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
by X-Gen Pharmaceuticals Inc.
- Reason
- Presence of Particulate Matter
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.
by G & W Laboratories, Inc.
- Reason
- Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601
by Alvogen, Inc
- Reason
- Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501
by Alvogen, Inc
- Reason
- Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401
by Alvogen, Inc
- Reason
- Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305
by Alvogen, Inc
- Reason
- Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.
by Alvogen, Inc
- Reason
- Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.
by Alvogen, Inc
- Reason
- Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05
by Alvogen, Inc
- Reason
- Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.