Class I · High risk Ongoing
DOXOrubin Hydrochloride Liposome injection
Reason Presence of Particulate matter: Particulate matter identified as glass.
Cystaran
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
What was recalled
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01
- Recalling firm
- Leadiant Biosciences, INC
- NDC code
- 54482-020-01
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0550-2018
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.
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Class II · Moderate risk Ongoing
cimzia
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
EPINEPHRINE Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Five-Star
Reason Stability Data Does Not Support Expiry Date.
Class III · Low risk Ongoing
Pitavastatin Tablets
Reason Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
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