FDA Drug recall D-1506-2015
HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxvill…
- FDA Drug
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxvill… by The Compounding Pharmacy, citing lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1506-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-02 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Compounding Pharmacy |
| Distribution | US |
Product
HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Identifiers
| code_info | All lots distributed between November 2014 and May 2015; 04172015@3, 6/16/2015; 03242015@49, 5/23/2015; 03272015@31, 5…All lots distributed between November 2014 and May 2015; 04172015@3, 6/16/2015; 03242015@49, 5/23/2015; 03272015@31, 5/26/2015; 05052015@51, 7/4/2015; 03252015@2, 5/24/2015; 03252015@30, 5/24/2015; 03302015@45, 5/29/2015; 04162015@26, 6/15/2015; 04212015@7, 6/20/2015; 04172015@71, 6/16/2015; 04292015@53, 6/28/2015; 04072015@53, 6/6/2015; 04272015@44, 6/26/2015 |
|---|
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-1506-2015%22
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