[pending] PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0419-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
The recalled product
- Product
- PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Appco Pharma LLC
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Lot:2404160C
- Exp.:2026/MAR
- 2406253C
- Exp.:2026/MAY
- 2407311C
- Exp.: 2026/JUL
- 2407312C
- Exp.:2026/JUL
- 2408350C
- 2505172C
- Exp.:2027/MAY
- 2506191C
- Exp.: 2027/JUN.
Distribution
Distributed nationwide across the United States.
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