FDA Drug recall D-0427-2017
HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-…
- FDA Drug
- Class III
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class III recall of HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-… by Pharm D Solutions, citing labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0427-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-12 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharm D Solutions |
| Distribution | AZ, WA |
Product
HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20
Reason
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Identifiers
| code_info | Lots: 07272016:03 Expiration Date: 01/23/2017 and 09142016:88 Expiration Date: 03/07/2017 |
|---|
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-0427-2017%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.