Lake Forest, IL, United States
Pharmedium Services, LLC recalls
13 recalls recorded since 2018, most recently on 16 March 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls13
Ongoing (FDA)0
Terminated or completed13
Class I (FDA)1
Terminated Class II Drugs
- Recall started
- 16 March 2020
- Terminated
- 14 February 2025
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Distribution
- Distributed Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1086-2020, D-1090-2020, D-1091-2020, D-1089-2020, D-1092-2020, D-1084-2020, D-1093-2020, D-1081-2020, D-1083-2020, D-1082-2020, D-1085-2020, D-1088-2020 and 1 more
- 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
- 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
- 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
- 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. N
- 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
- 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
- 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
- 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
- and 5 more product lines
Terminated Class III Drugs
- Recall started
- 16 December 2019
- Terminated
- 9 February 2021
- Reason
- Subpotent Drug
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0626-2020, D-0625-2020, D-0627-2020
- NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
- NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
- NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Terminated Class I Drugs
- Recall started
- 7 June 2019
- Terminated
- 2 June 2020
- Reason
- Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1488-2019
- Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78
Terminated Class II Drugs
- Recall started
- 2 January 2019
- Terminated
- 7 May 2020
- Reason
- Subpotent
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0374-2019
- 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% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton R
Terminated Class II Drugs
- Recall started
- 5 December 2018
- Terminated
- 2 October 2020
- Reason
- Sub-potent
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0334-2019, D-0333-2019
- Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland,
- Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS
Terminated Class II Drugs
- Recall started
- 24 July 2018
- Terminated
- 10 December 2018
- Reason
- CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
- Distribution
- Product was distributed throughout the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1045-2018, D-1044-2018, D-1043-2018
- 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
- 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
- 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Se
Terminated Class II Drugs
- Recall started
- 5 June 2018
- Terminated
- 6 February 2019
- Reason
- Superpotent and Subpotent
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0854-2018
- HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
Terminated Class III Drugs
- Recall started
- 10 April 2018
- Terminated
- 14 January 2020
- Reason
- cGMP deviations
- Distribution
- MA, WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0632-2018
- Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478
Terminated Class II Drugs
- Recall started
- 5 February 2018
- Terminated
- 24 April 2018
- Reason
- 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
- Product was distributed to SC, FL, NY, NY,WA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0423-2018, D-0424-2018, D-0422-2018
- 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
- 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
- 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
Terminated Class II Drugs
- Recall started
- 27 December 2017
- Terminated
- 7 May 2020
- Reason
- Lack of sterility assurance.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0454-2018, D-0428-2018, D-0437-2018, D-0450-2018, D-0447-2018, D-0451-2018, D-0441-2018, D-0463-2018, D-0429-2018, D-0430-2018, D-0469-2018, D-0442-2018 and 30 more
- Glycopyrrolate in all strengths, all doses, and all packaging.
- HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
- Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.
- Fentanyl Citrate Injection in all strengths, all doses, and all packaging.
- Labetalol HCl in all strengths, all doses, and all packaging.
- Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.
- Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
- Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
- and 34 more product lines
Terminated Class II Drugs
- Recall started
- 30 October 2017
- Terminated
- 7 May 2020
- Reason
- Subpotent Drug
- Distribution
- Nationwide within the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0220-2018
- ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 7103
Terminated Class II Drugs
- Recall started
- 26 September 2017
- Terminated
- 7 May 2020
- Reason
- Superpotent Drug
- Distribution
- Nationwide within the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0221-2018
- Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
Terminated Class III Drugs
- Recall started
- 26 September 2017
- Terminated
- 19 May 2020
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp. Date
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0131-2018, D-0130-2018, D-0132-2018
- morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78
- 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, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28
- HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.