Recall archive
29 recalls · page 1 of 2
Reported Apr 15, 2020
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PharMEDium Services, LLC
Matched: Brand · Product details — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
12 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 1, 2020
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Pharmedium Services, LLC
Matched: Brand · Product details — Subpotent Drug
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 10, 2019
Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.PharMEDium Services, LLC
Matched: Brand · Product · Product details — Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is…
FDA (openFDA drug enforcement)
Reported Jan 16, 2019
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%…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PharMEDium Services, LLC.
Matched: Brand · Product details — Subpotent
FDA (openFDA drug enforcement)
Reported Dec 26, 2018
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pharmedium Services, LLC
Matched: Brand · Product details — Sub-potent
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 15, 2018
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PharMEDium Services, LLC
Matched: Brand · Product details — CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 20, 2018
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PharMEDium Services, LLC
Matched: Brand · Product · Product details — Superpotent and Subpotent
FDA (openFDA drug enforcement)
Reported Apr 25, 2018
Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Pharmedium Services, LLC
Matched: Brand · Product · Product details — cGMP deviations
FDA (openFDA drug enforcement)
Reported Feb 28, 2018
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pharmedium Services, LLC
Matched: Brand — Lack of sterility assurance.
41 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 21, 2018
15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PharMEDium Services, LLC
Matched: Brand · Product · Product details — Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 24, 2018
ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pharmedium Services, LLC
Matched: Brand · Product details — Subpotent Drug
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 3, 2018
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Pharmedium Services, LLC
Matched: Brand · Product details — Labeling: Incorrect or Missing Lot and/or Exp. Date
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 22, 2017
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PharMEDium Services, LLC.
Matched: Brand · Product · Product details — Superpotent drug: out of specification result for potency
FDA (openFDA drug enforcement)
Reported Nov 1, 2017
Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pharmedium Services, LLC
Matched: Brand · Product · Product details — Subpotent Drug
14 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 27, 2017
Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PharMedium Services, LLC
Matched: Brand · Product details — Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jul 26, 2017
Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PharMedium Services, LLC
Matched: Brand · Product details — Lack of Assurance of Sterility; media fill failure at manufacturer
12 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 12, 2017
Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Pharmedium Services LLC
Matched: Brand · Product details — Labeling: Incorrect or Missing Lot and/or Exp Date
6 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 21, 2017
Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Pharmedium Services, LLC
Matched: Brand · Product · Product details — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
10 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 22, 2017
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Pharmedium Services, LLC
Matched: Brand · Product details — Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
FDA (openFDA drug enforcement)
Reported Nov 9, 2016
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pharmedium Services, LLC
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
FDA (openFDA drug enforcement)
Reported Oct 19, 2016
atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pharmedium Services, LLC
Matched: Brand · Product details — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
68 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 27, 2016
0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pharmedium Services, LLC
Matched: Brand · Product details — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
74 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 15, 2016
Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pharmedium Services, LLC
Matched: Brand · Product · Product details — Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250…
FDA (openFDA drug enforcement)
Reported Mar 23, 2016
NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Pharmedium Services, LLC
Matched: Brand · Product details — Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
1 more product in this recall
FDA (openFDA drug enforcement)
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