Class II · Moderate risk
Labetalol Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
labetalol HCl
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.
Drug: Labetalol
- Recalling firm
- Pharmedium Services, LLC
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0058-2017 · 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 Labetalol recalls
See all
Class II · Moderate risk
labetalol HCl 20 mg/4mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
Labetalol HCl Injection
Lack of Assurance of Sterility
Other recalls by Pharmedium Services, LLC
All 2015 recalls
Class II · Moderate risk
fentaNYL Citrate Injection 50 mcg per mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
fentaNYL Citrate Injection
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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