Class III · Low risk Ongoing
Hydromorphone HCL PF
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
HYDROmorphone HCl Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1256-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Hydromorphone recalls
See all
Class III · Low risk Terminated
HYDROmorphone Hydrochloride 50mg/50mL
Reason Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Class II · Moderate risk Terminated
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
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