Acetylcysteine 10% Oph Solution recalled over sterility concerns
- Recall date
- July 25, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Ranier's Compounding Laboratory recalls Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannett…
- Recall number
- D-1089-2018
- FDA classification
- Class II
- Brand / firm
- Ranier's Compounding Laboratory
- Sold / distributed
- Product was distributed within the state of Pennsylvania.
Why it was recalled
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
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