Why it was recalled
Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
Product description
Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving, TX, 75063, USA NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3
Lot numbers, UPCs & expiration codes
Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3. NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6.
Where it was sold
Nationwide
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-1263-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 21, 2013
- FDA report date
- May 7, 2014
- Quantity
- 296 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medisca Inc.
Original FDA data
Every field from FDA enforcement report D-1263-2014, exactly as published.
Show all FDA fields
- City
- Irving
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 67114
- Address
- 8300 Esters Blvd Ste 940
- Code information
- Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3. NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6.
- Postal code
- 75063-2272
- Report date
- May 7, 2014
- Product type
- Drugs
- Recall number
- D-1263-2014
- Classification
- Class I
- Recalling firm
- Medisca Inc.
- Product quantity
- 296 units
- Termination date
- Nov 16, 2016
- Reason for recall
- Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving, TX, 75063, USA NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 21, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2014