🍔 Food 💊 Drugs 🏥 Medical Devices
SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3 Class I

Reason: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.

Green Pharmaceuticals, Inc. 20220609 Terminated
Distributed: Nationwide within the United States
View Details
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Macleods Pharma Usa Inc 20220610 Terminated
Distributed: Product was distributed nationwide.
View Details
Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5 Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

PD-Rx Pharmaceuticals, Inc. 20220606 Terminated
Distributed: Nationwide
View Details
Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8 Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

PD-Rx Pharmaceuticals, Inc. 20220606 Terminated
Distributed: Nationwide
View Details
Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1 Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

PD-Rx Pharmaceuticals, Inc. 20220606 Terminated
Distributed: Nationwide
View Details
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Code 860002022116 Class I

Reason: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.

Buzzagogo, LLC 20220608 Terminated
Distributed: Product was distributed via the internet to consumers, retailers and to distributors who may have further distributed the product.
View Details
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02. Class II

Reason: Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.

Teva Pharmaceuticals USA Inc 20220614 Terminated
Distributed: Nationwide in the U.S.
View Details
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles. Class II

Reason: Failed Tablet/Capsule Specification; oversized tablet found in a bottle

SUN PHARMACEUTICAL INDUSTRIES INC 20220603 Terminated
Distributed: nationwide within the United States
View Details
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40. Class II

Reason: Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion

SUN PHARMACEUTICAL INDUSTRIES INC 20220610 Terminated
Distributed: Nationwide within the United States
View Details
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40. Class II

Reason: CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.

SUN PHARMACEUTICAL INDUSTRIES INC 20220603 Terminated
Distributed: Nationwide in the USA and Puerto Rico
View Details
Page 383 of 1,805 | Showing 10 recalls
Data provided by openFDA