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D-1653-2019 Class II Terminated

Recalled by RXQ Compounding LLC — Athens, OH

FDA drug recall D-1653-2019 was initiated by RXQ Compounding LLC on June 19, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated September 16, 2022). Affected quantity: N/A.

Recall Details

Product Type: Drugs
Report Date: August 14, 2019
Initiation Date: June 19, 2019
Termination Date: September 16, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

EDETATE DISODIUM 15% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0922-11

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide USA

Code Information

All lots within expiry

Other recalls by RXQ Compounding LLC

D-1670-2019 Class II — KETAMINE 10 MG/ML INJ SOL SYR (C-III), [a) 2 ML NDC: 70731-0132-02; b) 5 ML NDC: (June 19, 2019)
D-1696-2019 Class II — PROCAINE HCL 20 MG/ML (MDV) INJECTABLE SOLUTION, 30 ML per vial. RXQ Compoundin (June 19, 2019)
D-1636-2019 Class II — Ascorbic Acid 500 MG/ML (Non-Corn) INJ (MDV), 50 mL per vial, RXQ Compounding, 3 (June 19, 2019)
D-1702-2019 Class II — ROPIVICAINE 0.2%, INJ SOLN, 550 ML ON-Q PUMP. RXQ Compounding, 340 West State St (June 19, 2019)
D-1654-2019 Class II — Edetate Disodium150mg/mL PFV, 10 ML per Vial, RXQ Compounding, 340 West State St (June 19, 2019)
D-1679-2019 Class II — METHYLCOBALAMIN (PFV) 10 MG/ML INJECTABLE, 10 ML per vial, RXQ Compounding, 340 (June 19, 2019)
D-1681-2019 Class II — MIC B12 W/B6 (LIPOSTAT PLUS) 25/50/50/1/.175 MG/ML, 30 ML per vial, RXQ Compound (June 19, 2019)
D-1676-2019 Class II — MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Compoun (June 19, 2019)
D-1689-2019 Class II — NIACINAMIDE 100MG/ML, 10ML per vial, RXQ Compounding, 340 West State Street, Uni (June 19, 2019)
D-1703-2019 Class II — RXQ CAIN (PHENYLEP 1.5%/ LIDO 1% OPHTH SOL (PF), 1 ML PER VIAL, RXQ Compounding, (June 19, 2019)