FDA (Drugs) recall action 85212

PharMEDium Services, LLC recalled 13 products on 2020-04-15

The FDA (Drugs) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products: 13
Announced: 2020-04-15
Critical: 0
Units: 17,045

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–13 of 13

SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate infusions because of a lack of sterility assurance. The products were distributed nationwide in the US.
Product
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
Category
Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products because of a lack of sterility assurance.
Product
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
Category
Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
PharMEDium Services LLC is recalling 46 lots of nICARdipine HCl injection products because of a lack of sterility assurance.
Product
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01
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Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
PharMEDium Services, LLC is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.
Product
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
Category
Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
PharMEDium Services is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.
Product
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
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Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
PharMEDium Services is recalling 46 lots of ePHEDrine Sulfate syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.
Product
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
Category
Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls Hydromorphone Syringes Due to Sterility Assurance Issues
PharMEDium Services is recalling 46 lots of Hydromorphone in 0.9% Sodium Chloride HCl syringes due to a lack of sterility assurance.
Product
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
Category
Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns
PharMEDium Services is recalling 46 lots of ePHEDrine Sulfate syringes because the company could not ensure the products were sterile.
Product
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
Category
Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls Fentanyl Citrate Injection Lots for Sterility Assurance Issues
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products due to a lack of sterility assurance.
Product
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
Category
Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls 46 Lots of IV Products Due to Sterility Concerns
PharMEDium Services, LLC is recalling 46 lots of various IV products because of a lack of sterility assurance. The products were distributed nationwide in the US.
Product
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
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Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls ePHEDrine Sulfate IV Syringes Due to Sterility Concerns
PharMEDium Services is recalling 375 units of ePHEDrine Sulfate IV syringes because of a lack of sterility assurance.
Product
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
Category
Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls Succinylcholine Chloride Syringes Due to Sterility Assurance Issues
PharMEDium Services is recalling 46 lots of succinylcholine chloride syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.
Product
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04
Category
Distribution
0 states
SevereFDA (Drugs)··2020-04-15
PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Issues
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products because of a lack of sterility assurance.
Product
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
Category
Distribution
0 states