Why it was recalled
Lack of Assurance of Sterility
Product description
Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
Lot numbers, UPCs & expiration codes
Batch#: 11102107A2, Exp 4/9/202211232104A1, Exp 5/7/2022; 02212229A1, 11292103A2, Exp 5/22/2022; 12132105A2, Exp 5/24/2022; 02282207A1, Exp 5/29/2022; 03082209A1, Exp 6/6/2022; 03112231B, Exp 6/9/2022; 01042212A1, Exp 6/27/2022.
Where it was sold
Nationwide USA and Puerto Rico
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-1227-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 7, 2022
- FDA report date
- Jul 20, 2022
- Quantity
- 1,562 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- TMC Acquisition LLC dba Tailor Made Compounding
Original FDA data
Every field from FDA enforcement report D-1227-2022, exactly as published.
Show all FDA fields
- City
- Nicholasville
- State
- KY
- Status
- Ongoing
- Country
- United States
- Event ID
- 89909
- Address
- 200 Moore Dr
- Code information
- Batch#: 11102107A2, Exp 4/9/202211232104A1, Exp 5/7/2022; 02212229A1, 11292103A2, Exp 5/22/2022; 12132105A2, Exp 5/24/2022; 02282207A1, Exp 5/29/2022; 03082209A1, Exp 6/6/2022; 03112231B, Exp 6/9/2022; 01042212A1, Exp 6/27/2022.
- Postal code
- 40356-8512
- Report date
- Jul 20, 2022
- Product type
- Drugs
- Recall number
- D-1227-2022
- Classification
- Class II
- Recalling firm
- TMC Acquisition LLC dba Tailor Made Compounding
- Product quantity
- 1,562 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Mar 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2022