FDA Drug recall D-966-2013
H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STER…
- FDA Drug
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STER… by Beacon Hill Medical Pharmacy P C, citing lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-966-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-26 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Beacon Hill Medical Pharmacy P C |
| Distribution | US |
Product
H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Identifiers
| code_info | 01242013@23, 03132013@20, 04232013@21, 06112013@31, 03282013@24, 02042013@9, 03092013@6, 04122013@10, 04232013@24, 0523…01242013@23, 03132013@20, 04232013@21, 06112013@31, 03282013@24, 02042013@9, 03092013@6, 04122013@10, 04232013@24, 05232013@8, 06192013@26, 07102013@18, 07132013@6, 01072013@3, 02192013@10, 04172013@23, 06192013@28, 07102013@15, 07132013@8, 03232013@4, 03282013@22, 01032013@5, 01182013@24, 02052013@8, 03062013@5, 04122013@4, 04232013@26, 05132013@15, 05232013@5, 06182013@31, 06212013@12, 07132013@4, 03282013@27, 01032013@3, 01242013@16, 02192013@7, 03062013@2, 04122013@8, 04232013@29, 05232013@10, 06112013@28, 06182013@36, and 06242013@21. |
|---|
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-966-2013%22
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