Home / Recalls / PharMEDium Services, LLC / D-1088-2020

D-1088-2020 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

FDA drug recall D-1088-2020 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: 375 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
375 units

Product Description

ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09

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

193500012D, Exp 3/16/2020

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-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-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-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-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-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-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)

FDA data resources