Class III · Low risk
Hydromorphone HCL PF
Labeling: Incorrect or Missing Lot and/or Exp Date
All sterile drug preparations remaining within expiry prepared…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Drug: Hydromorphone
- Recalling firm
- Intrathecal Compounding Specialist, LLC
- Origin
- LA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0321-2018 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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 Intrathecal Compounding Specialist, LLC
All 2017 recalls
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
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