Why it was recalled
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Product description
Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
Lot numbers, UPCs & expiration codes
Lots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018;
Where it was sold
Nationwide in the USA.
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-0592-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 7, 2018
- FDA report date
- Mar 21, 2018
- Quantity
- 1460 GM
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Pharmaceutical Ingredients LLC
Original FDA data
Every field from FDA enforcement report D-0592-2018, exactly as published.
Show all FDA fields
- City
- Waterford
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 79420
- Address
- 6650 Highland Rd Ste 302
- Code information
- Lots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018;
- Postal code
- 48327-1665
- Report date
- Mar 21, 2018
- Product type
- Drugs
- Recall number
- D-0592-2018
- Classification
- Class II
- Recalling firm
- American Pharmaceutical Ingredients LLC
- Product quantity
- 1460 GM
- Termination date
- Dec 2, 2019
- Reason for recall
- Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 7, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2018