Class II · Moderate risk
Glutathione Injection USP
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
Lipo 8 Injection USP 200 mg/ml
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
- Recalling firm
- Medical Supply Liquidators Llc
- Origin
- IA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1530-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Medical Supply Liquidators Llc
All 2014 recalls
Class II · Moderate risk
L-Carnitine Injection USP 100 mg/ml
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
Class II · Moderate risk
G.A.C. 375 Injection USP
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
Class II · Moderate risk
Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml
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
Other unapproved drug recalls from 2014
All unapproved drug recalls
Class II · Moderate risk
B-Lipo
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
Class I · High risk
Professional Formexx Black
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
Swoll-250 Super Mass Builder Quad Stack
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
Estrastain Pro-Anabolic Mass and Hardening Complex
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
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