Class III · Low risk
Hydromorphone HCL PF
Labeling: Incorrect or Missing Lot and/or Exp Date
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2
Affected NDC
60652-0600-02
Compare with the code on your package — it is the most precise check available.
Drug: Hydromorphone
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0776-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Hydromorphone recalls
See all
Class III · Low risk
HYDROmorphone Hydrochloride 50mg/50mL
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Class II · Moderate risk
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Other recalls by SSM Health Care St. Louis DBA SSM St. Clare Health Center
All 2023 recalls
Class II · Moderate risk
FentaNYL citrate
Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS
Lack of Assurance of Sterility
Class II · Moderate risk
Succinylcholine chloride 100 mg in 5 mL syringe
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
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