American Pharmaceutical Ingredients LLC Recall: Phentolamine Mesylate USP for prescription
American Pharmaceutical Ingredients LLC Recall: Phentolamine Mesylate USP for prescription is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: American Pharmaceutical Ingredients LLC; Product: Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b)
| Recalling firm | American Pharmaceutical Ingredients LLC |
|---|---|
| Product | Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 |
| Reason for recall | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide within USA. |
| Recall initiated | 20180209 |
| Recall number | D-0516-2018 |
| Category | drug |
| State | MI |
| Country | United States |
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