Clonidine Hydrochloride Tablets — Class II drug recall D-1281-2015
Terminated recall by Mutual Pharmaceutical Company, Inc., reported 2015-08-05. cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispens
| Recall number | D-1281-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mutual Pharmaceutical Company, Inc., Philadelphia, PA, United States |
| Recall initiated | 2015-07-09 |
| Classified | 2015-07-30 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2016-10-13 |
| Reason classes | cgmp |
| NDC | 53489-0216-01, 53489-0216-10 |
Product
Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
Reason for recall
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1281-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.