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
Reported: March 7, 2018 Initiated: February 14, 2018 #D-0550-2018
Product Description
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
Reason for Recall
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Details
- Recalling Firm
- LEADIANT BIOSCIENCES, INC
- Units Affected
- 1,705 bottles
- Distribution
- Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: Italy
- Location
- Gaithersburg, MD
Frequently Asked Questions
What product 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. Recalled by LEADIANT BIOSCIENCES, INC. Units affected: 1,705 bottles.
Why was this product recalled? ▼
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 7, 2018. Severity: Low. Recall number: D-0550-2018.
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