🍔 Food 💊 Drugs 🏥 Medical Devices
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ Class II

Reason: Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

FDC Limited 20240425 Terminated
Distributed: New Jersey Only
View Details
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00 Class II

Reason: Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

Rubicon Research Private Limited 20240426 Ongoing
Distributed: Nationwide in the USA
View Details
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30. Class I

Reason: Sub-potent Drug; powder discoloration associated with decreased potency

Dr. Reddy's Laboratories, Inc. 20240408 Ongoing
Distributed: Nationwide in the USA
View Details
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30. Class I

Reason: Sub-potent Drug; powder discoloration associated with decreased potency

Dr. Reddy's Laboratories, Inc. 20240408 Ongoing
Distributed: Nationwide in the USA
View Details
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90. Class II

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Breckenridge Pharmaceutical, Inc 20240429 Ongoing
Distributed: US Nationwide.
View Details
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05. Class II

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Breckenridge Pharmaceutical, Inc 20240429 Ongoing
Distributed: US Nationwide.
View Details
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. Class II

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Breckenridge Pharmaceutical, Inc 20240429 Ongoing
Distributed: US Nationwide.
View Details
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77 Class III

Reason: Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.

Viatris Inc 20240425 Completed
Distributed: Nationwide within the united states
View Details
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05 Class III

Reason: Labeling: Wrong Barcode

Hikma Injectables USA Inc 20240430 Completed
Distributed: Nationwide within the United States
View Details
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01 Class II

Reason: Lack of Assurance of Sterility: Complaints of syringe breakage

Regeneron Pharmaceuticals Inc 20240423 Terminated
Distributed: USA Nationwide
View Details
Page 178 of 1,805 | Showing 10 recalls
Data provided by openFDA