Class II · Moderate risk Ongoing
BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA…
Reason Microbial contamination of non-sterile Products -
FDA Drug Recalls
411 recalls · Class II, newest first
Class II · Moderate risk Ongoing
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore…
Reason Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Class II · Moderate risk Ongoing
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC…
Reason Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx…
Reason Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II · Moderate risk Ongoing
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana…
Reason Failed Impurities/Degradation Specifications - at 18-month Stability testing
Class II · Moderate risk Ongoing
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454…
Reason Superpotent Drug
Class II · Moderate risk Ongoing
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)…
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…
Class II · Moderate risk Ongoing
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India…
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…
Class II · Moderate risk Ongoing
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India…
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…
Class II · Moderate risk Completed
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon…
Reason CGMP Deviations: sterile water not used for production
Class II · Moderate risk Completed
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon…
Reason CGMP Deviations: sterile water not used for production
Class II · Moderate risk Terminated
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle…
Reason Failed Dissolution Specifications: below specification results
Class II · Moderate risk Terminated
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India…
Reason Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Class II · Moderate risk Ongoing
Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E…
Reason Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class II · Moderate risk Ongoing
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC…
Reason Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa…
Reason CGMP Deviations