Why it was recalled
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Product description
Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356
Lot numbers, UPCs & expiration codes
Lot, exp: 7101804, 7111807, 7131807, 7151801, 7161804, 7181805, 7191801, 7201803, 7211801, 7221801, 7231805, 7241803, 7251803, 7261802, 7271801, 7281801, 7301805, 7311805, exp 7/19; 8021801, 8031801, 8041801, 8081802, 8091804, 8101803, 8111810, 8121801, 8141801, 8161803, 8171803, 8201801, 8251801, exp 8/19
Where it was sold
Nationwide 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-0223-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 28, 2018
- FDA report date
- Nov 14, 2018
- Quantity
- 10,280 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tailor Made Compounding
Original FDA data
Every field from FDA enforcement report D-0223-2019, exactly as published.
Show all FDA fields
- City
- Nicholasville
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 81337
- Address
- 200 Moore Dr
- Code information
- Lot, exp: 7101804, 7111807, 7131807, 7151801, 7161804, 7181805, 7191801, 7201803, 7211801, 7221801, 7231805, 7241803, 7251803, 7261802, 7271801, 7281801, 7301805, 7311805, exp 7/19; 8021801, 8031801, 8041801, 8081802, 8091804, 8101803, 8111810, 8121801, 8141801, 8161803, 8171803, 8201801, 8251801, exp 8/19
- Postal code
- 40356-8512
- Report date
- Nov 14, 2018
- Product type
- Drugs
- Recall number
- D-0223-2019
- Classification
- Class II
- Recalling firm
- Tailor Made Compounding
- Product quantity
- 10,280 Vials
- Termination date
- Aug 21, 2019
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Sep 28, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 7, 2018