🍔 Food 💊 Drugs 🏥 Medical Devices
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98. Class II

Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Pharma Nobis LLC 20231221 Ongoing
Distributed: Nationwide.
View Details
Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz, Distributed by AmerisourceBergen, 1 West First Ave, Conshochoken, PA 19428, NDC 46122-741-38 Class II

Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Pharma Nobis LLC 20231221 Ongoing
Distributed: Nationwide.
View Details
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15 Class II

Reason: Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

Dr. Reddy's Laboratories, Inc. 20240102 Completed
Distributed: USA Nationwide
View Details
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03 Class II

Reason: Presence of Foreign Tablets/Capsules

Rising Pharma Holding, Inc. 20231229 Ongoing
Distributed: Nationwide within the United States
View Details
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202. Class II

Reason: CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

Lupin Pharmaceuticals Inc. 20231220 Terminated
Distributed: Product was distributed nationwide.
View Details
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53 Class I

Reason: Defective Container: powder may leak out of the pouch

InvaGen Pharmaceuticals, Inc. 20231117 Completed
Distributed: Nationwide within the United States
View Details
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01 Class II

Reason: Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

Dr. Reddy's Laboratories, Inc. 20231215 Terminated
Distributed: US Nationwide.
View Details
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62. Class II

Reason: Lack of Sterility Assurance

Fresenius Medical Care Holdings, Inc. 20231228 Ongoing
Distributed: Nationwide within the United States
View Details
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0 Class II

Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Seaway Pharma Inc. 20231228 Ongoing
Distributed: MI, PA
View Details
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7. Class II

Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Seaway Pharma Inc. 20231228 Ongoing
Distributed: MI, PA
View Details
Page 204 of 1,805 | Showing 10 recalls
Data provided by openFDA