Drug 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
D-0427-2017
Product summary
- Event
- Event 75552
- Status
- Terminated
- Classification
- Class III
- Quantity
- 112 bottles
- Official record key
drug-enforcement:D-0427-2017
Official wording
Reason: Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Code information: Lots: 07272016:03 Expiration Date: 01/23/2017 and 09142016:88 Expiration Date: 03/07/2017
Distribution pattern: AZ and WA
Derived failure modes
-
Labeling or packaging
Labeling; Error