Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
Reported: August 13, 2025 Initiated: July 25, 2025 #D-0566-2025
Product Description
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Details
- Recalling Firm
- Alembic Pharmaceuticals Limited
- Units Affected
- 9,492 bottles
- Distribution
- Nationwide in the USA.
- Location
- Panchmahal, N/A
Frequently Asked Questions
What product was recalled? ▼
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31. Recalled by Alembic Pharmaceuticals Limited. Units affected: 9,492 bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 13, 2025. Severity: Moderate. Recall number: D-0566-2025.
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