Why it was recalled
Lack of Sterility Assurance.
Product description
Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lot numbers, UPCs & expiration codes
Lot #: 05022019:50 Exp. 10/29/2019; 05082019:91 Exp. 06/08/2019
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1327-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 23, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 11 vials
- Recall type
- FDA Mandated
- Recalling firm
- Pharm D Solutions, LLC
Original FDA data
Every field from FDA enforcement report D-1327-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 82941
- Address
- 1304 S Loop W
- Code information
- Lot #: 05022019:50 Exp. 10/29/2019; 05082019:91 Exp. 06/08/2019
- Postal code
- 77054-4010
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1327-2019
- Classification
- Class II
- Recalling firm
- Pharm D Solutions, LLC
- Product quantity
- 11 vials
- Termination date
- Feb 5, 2021
- Reason for recall
- Lack of Sterility Assurance.
- Voluntary / mandated
- FDA Mandated
- Product description
- Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 23, 2019
- Initial firm notification
- Press Release
- Center classification date
- Jun 7, 2019