Recalls / Class III
Class IIID-0427-2017
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
- Affected lot / code info
- Lots: 07272016:03 Expiration Date: 01/23/2017 and 09142016:88 Expiration Date: 03/07/2017
Why it was recalled
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Recalling firm
- Firm
- Pharm D Solutions, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1304 S Loop W, Houston, Texas 77054-4010
Distribution
- Quantity
- 112 bottles
- Distribution pattern
- AZ and WA
Timeline
- Recall initiated
- 2016-10-12
- FDA classified
- 2017-01-09
- Posted by FDA
- 2017-01-18
- Terminated
- 2017-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0427-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.