Home / Recalls / PharMEDium Services, LLC. / D-0374-2019

D-0374-2019 Class II Terminated

Recalled by PharMEDium Services, LLC. — Cleveland, MS

FDA drug recall D-0374-2019 was initiated by PharMEDium Services, LLC. on January 2, 2019 and is designated Class II. Reason for recall: Subpotent The recall status is terminated (terminated May 7, 2020). Affected quantity: 7,711 syringes.

Recall Details

Product Type: Drugs
Report Date: January 16, 2019
Initiation Date: January 2, 2019
Termination Date: May 7, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,711 syringes

Product Description

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.

Reason for Recall

Subpotent

Distribution Pattern

Product was distributed throughout the United States.

Code Information

Service Code 2K2466 and 2K2470 183320004S, 183330008S, 183340002S, 183340003S, 183300004S, 183310007S, 183370041S, 183310043S, 183370042S, 183320003S, 183380007S, 183250013S, 183250014S, 183320005S, 183330009S, 183370007S, 183390044S, 183400006S, 183410003S.

Other recalls by PharMEDium Services, LLC.

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-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-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-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-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-1089-2020 Class II — fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 (March 16, 2020)
D-1083-2020 Class II — rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, Ph (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-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-1082-2020 Class II — nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 1 (March 16, 2020)