Home / Recalls / Premier Pharmacy Labs Inc / D-0701-2018

D-0701-2018 Class II Terminated

Recalled by Premier Pharmacy Labs Inc — Weeki Wachee, FL

Recall Details

Product Type
Drugs
Report Date
May 2, 2018
Initiation Date
April 11, 2018
Termination Date
September 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3570 syringes

Product Description

Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10

Reason for Recall

Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Distribution Pattern

Nationwide in the USA

Code Information

Lots: HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, HYD030118IJDSE BUD: 05/30/2018

Other recalls by Premier Pharmacy Labs Inc

  • D-1424-2019 Class II — Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Con (June 18, 2019)
  • D-1426-2019 Class II — Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, (June 18, 2019)
  • D-1413-2019 Class II — ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, (June 18, 2019)
  • D-1414-2019 Class II — Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/ (June 18, 2019)
  • D-1425-2019 Class II — Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 m (June 18, 2019)
  • D-1420-2019 Class II — Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, P (June 18, 2019)
  • D-1411-2019 Class II — Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx on (June 18, 2019)
  • D-1421-2019 Class II — Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Pre (June 18, 2019)
  • D-1415-2019 Class II — Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single- (June 18, 2019)
  • D-1417-2019 Class II — Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL S (June 18, 2019)