Why it was recalled
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Product description
G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Lot numbers, UPCs & expiration codes
All lot numbers and exp dates
Where it was sold
Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.
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-1531-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 25, 2014
- FDA report date
- Aug 13, 2014
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medical Supply Liquidators Llc
Original FDA data
Every field from FDA enforcement report D-1531-2014, exactly as published.
Show all FDA fields
- City
- Clive
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 68626
- Address
- 10500 Hickman Rd Ste F
- Code information
- All lot numbers and exp dates
- Postal code
- 50325-3706
- Report date
- Aug 13, 2014
- Product type
- Drugs
- Recall number
- D-1531-2014
- Classification
- Class II
- Recalling firm
- Medical Supply Liquidators Llc
- Termination date
- Mar 14, 2017
- Reason for recall
- Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
- Distribution pattern
- Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.
- Recall initiation date
- Jun 25, 2014
- Initial firm notification
- Center classification date
- Aug 6, 2014