FDA Drug recall D-1164-2014
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes
- FDA Drug
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes by Rx South, citing crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1164-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-28 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Rx South |
| Distribution | MD, VA |
Product
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***
Reason
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Identifiers
| code_info | Lot number: 12052013:03 Expiration date: 06/03/2014 |
|---|
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-1164-2014%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.