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Prescription Drugs

💊 Drugs • 11,927 recalls

methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.

Hikma Pharmaceuticals USA

Class I - Dangerous

Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.

Jan 14, 2020 Prescription Drugs Nationwide View Details →

Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.

Mylan Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Jan 7, 2020 Prescription Drugs View Details →

Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

RemedyRepack

Class I - Dangerous

CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

Dec 11, 2019 Prescription Drugs View Details →

NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.

Advanced Accelerator Applications USA

Class I - Dangerous

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

Jan 10, 2020 Prescription Drugs Nationwide View Details →

Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131

Denton Pharma

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Dec 20, 2019 Prescription Drugs Nationwide View Details →

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)

Preferred Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Jan 7, 2020 Prescription Drugs View Details →

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)

Preferred Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Jan 7, 2020 Prescription Drugs View Details →

Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.

AVKARE

Class I - Dangerous

Failed Impurities/Degradation Specifications: High out of specification results for related compounds.

Jan 7, 2020 Prescription Drugs Nationwide View Details →

Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India

Sun Pharmaceutical Industries

Class I - Dangerous

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Jan 14, 2020 Prescription Drugs View Details →

Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ

Sun Pharmaceutical Industries

Class I - Dangerous

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

Dec 26, 2019 Prescription Drugs View Details →

Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX

Motto International

Class I - Dangerous

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Dec 17, 2019 Prescription Drugs View Details →

Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704

McGuff Compounding Pharmacy Services

Class I - Dangerous

Presence of Particulate Matter: filmy/cloudy particulate observed in vial.

Jan 10, 2019 Prescription Drugs Nationwide View Details →

Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601

Letco Medical

Class I - Dangerous

Subpotent

Jan 10, 2020 Prescription Drugs View Details →

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.

Hikma Pharmaceuticals USA

Class I - Dangerous

Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

Dec 17, 2019 Prescription Drugs Nationwide View Details →

Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX

Motto International

Class I - Dangerous

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Dec 17, 2019 Prescription Drugs View Details →

Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)

Lupin Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.

Jan 10, 2020 Prescription Drugs Nationwide View Details →

Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX

Motto International

Class I - Dangerous

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Dec 17, 2019 Prescription Drugs View Details →

Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX

Motto International

Class I - Dangerous

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Dec 17, 2019 Prescription Drugs View Details →

Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.

AuroMedics Pharma

Class I - Dangerous

Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.

Dec 2, 2019 Prescription Drugs Nationwide View Details →

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.

Hikma Pharmaceuticals USA

Class I - Dangerous

Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

Dec 17, 2019 Prescription Drugs Nationwide View Details →

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