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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 9561–9580 of 17,793 recalls

Class IITerminated

Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. # 101, Las Vegas, NV 89119 (702) 791-3800

Partell Specialty Pharmacy

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

March 22, 2018 · DrugView details →

Class IITerminated

Testosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Partell Specialty Pharmacy

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

March 22, 2018 · DrugView details →

Class IITerminated

Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Partell Specialty Pharmacy

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

March 22, 2018 · DrugView details →

Class IITerminated

Estradiol 25 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Partell Specialty Pharmacy

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

March 22, 2018 · DrugView details →

Class IITerminated

Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Partell Specialty Pharmacy

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

March 22, 2018 · DrugView details →

Class IIITerminated

Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.

Mayne Pharma Inc

Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.

March 21, 2018 · DrugView details →

Class IITerminated

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

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

March 19, 2018 · DrugView details →

Class IIITerminated

Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.

Glenmark Pharmaceuticals Inc., USA

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.

March 19, 2018 · DrugView details →

Class IIITerminated

Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01

Lake Erie Medical & Surgical Supply Inc

Labeling: Incorrect or Missing Lot and/or Exp Date

March 19, 2018 · DrugView details →

Class ITerminated

All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

Bayer HealthCare Pharmaceuticals, Inc.

Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.

March 15, 2018 · DrugView details →

Class IIITerminated

buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788

InvaGen Pharmaceuticals, Inc.

Failed Dissolution Specifications; during stability testing

March 15, 2018 · DrugView details →

Class IIITerminated

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03

InvaGen Pharmaceuticals, Inc.

Failed Dissolution Specifications; during stability testing

March 15, 2018 · DrugView details →

Class IIITerminated

Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.

Alva-Amco Pharmacal Companies., Inc.

Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.

March 9, 2018 · DrugView details →

Class IIITerminated

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, Inc.

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

March 9, 2018 · DrugView details →

Class IIITerminated

Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90

Dr. Reddy's Laboratories, Inc.

Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.

March 8, 2018 · DrugView details →

Class IITerminated

E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01

Bracco Diagnostics Inc.

Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.

March 8, 2018 · DrugView details →

Class ITerminated

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

Jimmy Weber

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.

March 8, 2018 · DrugView details →

Class IITerminated

Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.

Apollo Care

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

March 7, 2018 · DrugView details →

Class IITerminated

Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3

American Pharmaceutical Ingredients LLC

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

March 7, 2018 · DrugView details →

Class IITerminated

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

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

March 7, 2018 · DrugView details →

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