Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.

Mar 19, 2018 Prescription Drugs Nationwide View Details →

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.

Akorn

Class I - Dangerous

Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.

Mar 29, 2018 Prescription Drugs Nationwide View Details →

Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021

Jimmy Weber

Class I - Dangerous

Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.

Mar 8, 2018 Prescription Drugs View Details →

Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27

Paddock Laboratories

Class I - Dangerous

Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.

Feb 26, 2018 Prescription Drugs Nationwide View Details →

Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1

Amneal Pharmaceuticals

Class I - Dangerous

Presence of particulate matter

Dec 15, 2017 Prescription Drugs Nationwide View Details →

Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.

Apollo Care

Class I - Dangerous

Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.

Mar 7, 2018 Prescription Drugs View Details →

Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01

Pine Pharmaceuticals

Class I - Dangerous

Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.

Mar 5, 2018 Prescription Drugs View Details →

Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.

Teva Pharmaceuticals USA

Class I - Dangerous

Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.

Mar 19, 2018 Prescription Drugs View Details →

DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.

Fresenius Medical Care Renal Therapies Group

Class I - Dangerous

Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.

Dec 20, 2017 Prescription Drugs View Details →

Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.

Akorn

Class I - Dangerous

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Mar 9, 2018 Prescription Drugs Nationwide View Details →

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