Home / Recalls / PharMEDium Services, LLC / D-0423-2018

D-0423-2018 Class II Terminated

Recalled by PharMEDium Services, LLC — Dayton, NJ

Recall Details

Product Type
Drugs
Report Date
February 21, 2018
Initiation Date
February 5, 2018
Termination Date
April 24, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21 Cassettes

Product Description

0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC

Reason for Recall

Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.

Distribution Pattern

Product was distributed to SC, FL, NY, NY,WA

Code Information

Lot #: 180030029D, Exp 2/18/18

Other recalls by PharMEDium Services, LLC

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  • 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-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-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-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-1089-2020 Class II — fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 (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)