FDA Drug recall D-1291-2020
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind
- FDA Drug
- Class III
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class III recall of Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind by Unichem Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1291-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-05-26 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Unichem Pharmaceuticals Usa |
| Distribution | US |
Product
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01
Reason
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Identifiers
| ndc | 29300-468-05 |
|---|---|
| ndc | 29300-468-10 |
| ndc | 29300-468-50 |
| ndc | 29300-468-01 |
| ndc | 29300-136-01 |
| ndc | 29300-136-05 |
| ndc | 29300-136-10 |
| ndc | 29300-136-50 |
| ndc | 29300-137-01 |
| ndc | 29300-137-05 |
| ndc | 29300-137-10 |
| ndc | 29300-137-25 |
| ndc | 29300-135-01 |
| ndc | 29300-135-05 |
| ndc | 29300-135-10 |
| ndc | 29300-135-50 |
| code_info | Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1291-2020%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.