FDA DrugsClass II
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactu...
Published: April 8, 2026Recall ID: D-0420-2026Category: drugsCountry: US
Reason for Recall / Hazard
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Product Description & Identification
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
Affected Products
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
Additional Source Details
| Field | Value |
|---|---|
| City | Piscataway |
| State | NJ |
| Openfda › Unii | X0Z7454B90 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 198141 |
| Openfda › Rxcui › 2 | 312593 |
| Openfda › Rxcui › 3 | 312594 |
| Openfda › Spl id | 99deacbe-59a1-4e72-8b23-d0f470e2633d |
| Openfda › Brand name | PRAZOSIN HYDROCHLORIDE |
| Openfda › Spl set id | 82a84f69-4742-453f-96c8-532fb7df44c6 |
| Openfda › Package ndc › 1 | 70377-066-11 |
| Openfda › Package ndc › 2 | 70377-067-11 |
| Openfda › Package ndc › 3 | 70377-068-11 |
| Openfda › Product ndc › 1 | 70377-066 |
| Openfda › Product ndc › 2 | 70377-067 |
| Openfda › Product ndc › 3 | 70377-068 |
| Openfda › Generic name | PRAZOSIN HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | PRAZOSIN HYDROCHLORIDE |
| Openfda › Manufacturer name | Biocon Pharma Inc. |
| Openfda › Application number | ANDA213406 |
| Openfda › Is original packager | true |
| Event id | 98658 |
| Address 1 | 262 Old New Brunswick Rd Ste N |
| Code info | Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY. |
| Postal code | 08854-3888 |
| Report date | 20260408 |
| Product type | Drugs |
| Product quantity | 58,896 bottles- 100's count |
| Reason for recall | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260327 |
| Initial firm notification | |
| Center classification date | 20260331 |
Overview
- Recalling FirmAppco Pharma LLC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S.A. Nationwide