chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
Reported: September 10, 2025 Initiated: August 18, 2025 #D-0619-2025
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
Reason for Recall
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Details
- Recalling Firm
- Amneal Pharmaceuticals, LLC
- Units Affected
- 3,363 100-count bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.. Recalled by Amneal Pharmaceuticals, LLC. Units affected: 3,363 100-count bottles.
Why was this product recalled? ▼
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 10, 2025. Severity: Moderate. Recall number: D-0619-2025.
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