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6-3-2018

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed below. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals.

FDA - U.S. Food and Drug Administration

6-3-2018

Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results

Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results

An elevated impurity has the potential to decrease effectiveness of the product in patients. Posted: 03/06/2018

FDA - U.S. Food and Drug Administration

1-5-2018

METHYLPREDNISOLONE Tablet [Zydus Pharmaceuticals (USA) Inc.]

METHYLPREDNISOLONE Tablet [Zydus Pharmaceuticals (USA) Inc.]

Updated Date: May 1, 2018 EST

US - DailyMed

1-5-2018

METHYLPREDNISOLONE Tablet [Cadila Healthcare Limited]

METHYLPREDNISOLONE Tablet [Cadila Healthcare Limited]

Updated Date: May 1, 2018 EST

US - DailyMed

17-4-2018

METHYLPREDNISOLONE Tablet [REMEDYREPACK INC.]

METHYLPREDNISOLONE Tablet [REMEDYREPACK INC.]

Updated Date: Apr 17, 2018 EST

US - DailyMed

28-2-2018

Medrol (methylprednisolone) vs. Prednisone

Medrol (methylprednisolone) vs. Prednisone

Medrol (methylprednisolone) and prednisone are glucocorticoids indicated to treat or manage many conditions, endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergies, ophthalmic (eye) diseases, respiratory diseases, hematologic disorders, neoplastic diseases (cancers), edematous states, gastrointestinal diseases, and others.

US - RxList

29-1-2018

MEDPREDKIT PLUS (Methylprednisolone Tablets) Kit [MedArbor LLC]

MEDPREDKIT PLUS (Methylprednisolone Tablets) Kit [MedArbor LLC]

Updated Date: Jan 29, 2018 EST

US - DailyMed

19-1-2018

METHYLPREDNISOLONE Tablet [Major Pharmaceuticals]

METHYLPREDNISOLONE Tablet [Major Pharmaceuticals]

Updated Date: Jan 19, 2018 EST

US - DailyMed

5-1-2018

DEPO-MEDROL (Methylprednisolone Acetate) Injection, Suspension [Cardinal Health]

DEPO-MEDROL (Methylprednisolone Acetate) Injection, Suspension [Cardinal Health]

Updated Date: Jan 5, 2018 EST

US - DailyMed

3-1-2018

Methylprednisolone

Methylprednisolone

Methylprednisolone is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions. This medication is a corticosteroid hormone.

US - RxList

2-1-2018

MEDPREDKIT (Methylprednisolone Tablets) Kit [MedArbor LLC]

MEDPREDKIT (Methylprednisolone Tablets) Kit [MedArbor LLC]

Updated Date: Jan 2, 2018 EST

US - DailyMed

2-1-2018

MEDROL (Methylprednisolone) Tablet [Zoetis Inc.]

MEDROL (Methylprednisolone) Tablet [Zoetis Inc.]

Updated Date: Jan 2, 2018 EST

US - DailyMed

28-12-2017

DEPO-MEDROL (Methylprednisolone Acetate) Injection, Suspension [Zoetis Inc.]

DEPO-MEDROL (Methylprednisolone Acetate) Injection, Suspension [Zoetis Inc.]

Updated Date: Dec 28, 2017 EST

US - DailyMed

20-12-2017

MEDROL (Methylprednisolone) Tablet [A-S Medication Solutions]

MEDROL (Methylprednisolone) Tablet [A-S Medication Solutions]

Updated Date: Dec 20, 2017 EST

US - DailyMed

20-12-2017

METHYLPREDNISOLONE Tablet [Preferred Pharmaceuticals, Inc.]

METHYLPREDNISOLONE Tablet [Preferred Pharmaceuticals, Inc.]

Updated Date: Dec 20, 2017 EST

US - DailyMed

18-12-2017

METHYLPREDNISOLONE ACETATE Injection, Suspension [Teva Parenteral Medicines, Inc.]

METHYLPREDNISOLONE ACETATE Injection, Suspension [Teva Parenteral Medicines, Inc.]

Updated Date: Dec 18, 2017 EST

US - DailyMed

12-12-2017

METHYLPREDNISOLONE Tablet [Actavis Pharma, Inc.]

METHYLPREDNISOLONE Tablet [Actavis Pharma, Inc.]

Updated Date: Dec 12, 2017 EST

US - DailyMed

7-12-2017

METHYLPREDNISOLONE ACETATE Injection, Suspension [Proficient Rx LP]

METHYLPREDNISOLONE ACETATE Injection, Suspension [Proficient Rx LP]

Updated Date: Dec 7, 2017 EST

US - DailyMed

5-12-2017

METHYLPREDNISOLONE Tablet [BluePoint Laboratories]

METHYLPREDNISOLONE Tablet [BluePoint Laboratories]

Updated Date: Dec 5, 2017 EST

US - DailyMed

5-12-2017

METHYLPREDNISOLONE Tablet [American Health Packaging]

METHYLPREDNISOLONE Tablet [American Health Packaging]

Updated Date: Dec 5, 2017 EST

US - DailyMed

16-11-2017

METHYLPREDNISOLONE Tablet [Greenstone LLC]

METHYLPREDNISOLONE Tablet [Greenstone LLC]

Updated Date: Nov 16, 2017 EST

US - DailyMed

16-11-2017

MEDROL (Methylprednisolone) Tablet [Pharmacia And Upjohn Company LLC]

MEDROL (Methylprednisolone) Tablet [Pharmacia And Upjohn Company LLC]

Updated Date: Nov 16, 2017 EST

US - DailyMed

25-10-2017

DEPO-MEDROL (Methylprednisolone Acetate) Injection, Suspension [REMEDYREPACK INC.]

DEPO-MEDROL (Methylprednisolone Acetate) Injection, Suspension [REMEDYREPACK INC.]

Updated Date: Oct 25, 2017 EST

US - DailyMed

4-10-2017

METHYLPREDNISOLONE Tablet [PD-Rx Pharmaceuticals, Inc.]

METHYLPREDNISOLONE Tablet [PD-Rx Pharmaceuticals, Inc.]

Updated Date: Oct 4, 2017 EST

US - DailyMed

7-9-2017

METHYLPREDNISOLONE Tablet [A-S Medication Solutions]

METHYLPREDNISOLONE Tablet [A-S Medication Solutions]

Updated Date: Sep 7, 2017 EST

US - DailyMed

9-8-2017

MEDROL (Methylprednisolone) Tablet [REMEDYREPACK INC.]

MEDROL (Methylprednisolone) Tablet [REMEDYREPACK INC.]

Updated Date: Aug 9, 2017 EST

US - DailyMed

1-8-2017

News and press releases:  CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins

News and press releases: CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins

Current formulations containing lactose will be replaced with lactose-free formulations

Europe - EMA - European Medicines Agency

18-7-2017

METHYLPREDNISOLONE Tablet [NuCare Pharmaceuticals,Inc.]

METHYLPREDNISOLONE Tablet [NuCare Pharmaceuticals,Inc.]

Updated Date: Jul 18, 2017 EST

US - DailyMed

14-7-2017

METHYLPREDNISOLONE Tablet [Par Pharmaceutical]

METHYLPREDNISOLONE Tablet [Par Pharmaceutical]

Updated Date: Jul 14, 2017 EST

US - DailyMed

21-6-2017

Veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in target species cattle

Veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in target species cattle

Veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in target species cattle (Active substance: Methylprednisolone hydrogen succinate) - Community Referrals - Art 35 - Commission Decision (2017)4364 of Wed, 21 Jun 2017 European Medicines Agency (EMA) procedure number: EMEA/V/A/119

Europe -DG Health and Food Safety