FDA Drug recall D-1281-2015
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…
- FDA Drug
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of 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… by Mutual Pharmaceutical, citing cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1281-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-09 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mutual Pharmaceutical |
| Distribution | n/a |
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
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Identifiers
| code_info | Lot #: a) 6643901, exp 5/16, 6677201, exp 1/17; b) 6677101, EXP 1/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1281-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.