FDA Drug recall D-1211-2018
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class III recall of Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc by Hetero Labs Unit Iii, citing presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1211-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-09-12 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hetero Labs Unit Iii |
| Distribution | IN, LA |
Product
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
Reason
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Identifiers
| ndc | 31722-595-30 |
|---|---|
| ndc | 31722-595-90 |
| ndc | 31722-595-31 |
| ndc | 31722-595-32 |
| ndc | 31722-596-30 |
| ndc | 31722-596-90 |
| ndc | 31722-596-31 |
| ndc | 31722-596-32 |
| code_info | Lot #: E181370, Exp. 5/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Hetero Labs Unit Iii
- Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854
FDA Drug · Class II · 2018-08-08 · Hetero Labs Unit Iii - Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc
FDA Drug · Class II · 2018-02-14 · Hetero Labs Unit Iii - Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufact…
FDA Drug · Class III · 2018-01-24 · Hetero Labs Unit Iii - Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc…
FDA Drug · Class II · 2017-12-06 · Hetero Labs Unit Iii
All Hetero Labs Unit Iii recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1211-2018%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.