FDA-Drug2025-09-24Class II
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Hazard
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Sold states
Nationwide in the USA
Affected count
2,708 cartons
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0647-2025More Amerisource Health Services LLC recalls
- FDA-Drug2026-05-27Amerisource Health Services Primidone Tablets recalled for trace Acemetacin contamination
- FDA-Drug2026-05-27Amerisource Primidone 250 mg tablets recalled for cross-contamination with Acemetacin
- FDA-Drug2026-04-01Meclizine Hydrochloride 12.5 mg tablets recalled for failed specifications
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