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D-1083-2020 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

FDA drug recall D-1083-2020 was initiated by PharMEDium Services, LLC on March 16, 2020 and is designated Class II. Reason for recall: Firm is recalling 46 lots of various products because of a lack of sterility assurance. The recall status is terminated (terminated February 14, 2025). Affected quantity: 4625 units.

Recall Details

Product Type: Drugs
Report Date: April 15, 2020
Initiation Date: March 16, 2020
Termination Date: February 14, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4625 units

Product Description

rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10

Reason for Recall

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Distribution Pattern

Distributed Nationwide in the US

Code Information

193510017D 3/17/2020 193530001D 3/19/2020 193540002D 3/22/2020

Other recalls by PharMEDium Services, LLC

D-1081-2020 Class II — ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL (March 16, 2020)
D-1082-2020 Class II — nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 1 (March 16, 2020)
D-1086-2020 Class II — succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For (March 16, 2020)
D-1092-2020 Class II — fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For I (March 16, 2020)
D-1084-2020 Class II — HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 (March 16, 2020)
D-1091-2020 Class II — ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 (March 16, 2020)
D-1089-2020 Class II — fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 (March 16, 2020)
D-1085-2020 Class II — fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, (March 16, 2020)
D-1088-2020 Class II — ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL sy (March 16, 2020)
D-1090-2020 Class II — ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD S (March 16, 2020)