Multi-event October 2016 FDA Recall Drug by Pharm D Solutions, Llc
This Multi-event Class III drug recall was voluntarily initiated by Pharm D Solutions, Llc on October 12, 2016 for the product Drug. The FDA reported the reason for recall as labeling; error on declared strength; product description incorrectly states hcg 7500 units instead of 5000 units. the primary panel is correct. The product was distributed in AZ and WA and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0427-2017
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
10-12-2016
01-18-2017
112 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AZ and WA
05-11-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lots: 07272016:03 Expiration Date: 01/23/2017 and 09142016:88 Expiration Date: 03/07/2017
Recall Number: D-0426-2017
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
10-12-2016
01-18-2017
4 mL: 510 vials, 5 mL: 486 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AZ and WA
05-11-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04
Batch or Lot Expiration Information
Lot# Lot: 09122016:34, exp 09/07/2017
