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Drug FDA Class II Ongoing cGMP deviation

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)

Amerisource Health Services LLC Published Sep 24, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Amerisource Health Services LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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.

Hazards

Microbial Contamination in Packaging Materials · primary

Affected products (1)

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)

CHLORPROMAZINE HYDROCHLORIDE · 873 cartons

NDC: 60687-419, 60687-430, 60687-441, 60687-452, 60687-463, 60687-419-11, 60687-419-01, 60687-430-11, 60687-430-01, 60687-430-65, 60687-441-11, 60687-441-01, 60687-452-11, 60687-452-01, 60687-463-11, 60687-463-01
Lot codes: 1021640
Code info: Lot: 1021640, Exp 10/31/2026; 1022639, Exp 01/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 27, 2025
  2. Published
    Sep 24, 2025
Recall number
D-0650-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.