CLASS II Drug recall · Reported 26 Mar 2014 · FDA Enforcement Report
Hydroxyprogesterone Caproate 250mg/ml recalled by RX South
RX South is recalling Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil injectable solution, in single dose, distributed in Maryland, Virginia. The recall was initiated on 28 Jan 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1164-2014
- FDA event ID
- 67432
- Recalling firm
- RX South, Chester, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jan 2014
- FDA classified
- 17 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Jan 2014 | Recall initiated by company | |
| 17 Mar 2014 | Classified by FDA | +48 days |
| 26 Mar 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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***
Where it was distributed
Product was distributed in Virginia and Maryland.
Questions about this recall
Is Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil injectable solution, in single dose recalled?
Yes. RX South recalled Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil injectable solution, in single dose on 28 Jan 2014. The recall is Class II and its status is Terminated. Recall number D-1164-2014.
Why was it recalled?
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Which lots are affected?
Lot number: 12052013:03 Expiration date: 06/03/2014
Where was it sold?
Product was distributed in Virginia and Maryland.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RX South
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Medi-bolic Booster Injectable (methionine 3 mg/mL recalled by RX South | RX South | Manufacturing (CGMP) Deviations | Nationwide |