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D-0988-2017 Class II Terminated

Recalled by PharMedium Services, Llc — Sugar Land, TX

FDA drug recall D-0988-2017 was initiated by PharMedium Services, Llc on June 26, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; media fill failure at manufacturer The recall status is terminated (terminated April 29, 2020). Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
July 26, 2017
Initiation Date
June 26, 2017
Termination Date
April 29, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48

Reason for Recall

Lack of Assurance of Sterility; media fill failure at manufacturer

Distribution Pattern

Nationwide

Code Information

Lot: 171320001D, 8/10/2017

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-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-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-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-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-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-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-1082-2020 Class II — nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 1 (March 16, 2020)

FDA data resources