FDA (Drugs) recall action 68626

Medical Supply Liquidators Llc recalled 15 products on 2014-08-13

The FDA (Drugs) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.

Products: 15
Announced: 2014-08-13
Critical: 0
Units: —

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

1–15 of 15

ModerateFDA (Drugs)··2014-08-13
FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide
Medical Supply Liquidators LLC is recalling Vitamin B12 Cyanocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.
Product
Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Distribution
0 states
SevereFDA (Drugs)··2014-08-13
BCAA 4% Injection Recalled for Lack of FDA Approval
Medical Supply Liquidators LLC is recalling BCAA 4% Branched Chain Amino Acid Injection USP because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.
Product
BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Distribution
0 states
SevereFDA (Drugs)··2014-08-13
FDA Recalls Unapproved Vitamin B6 Injection Vials Nationwide
Medical Supply Liquidators LLC is recalling Vitamin B6 Pyridoxine HCL for Injection because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.
Product
Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.
Category
Distribution
0 states
ModerateFDA (Drugs)··2014-08-13
FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide and Abroad
Medical Supply Liquidators LLC is recalling Vitamin B12 Cyanocobalamin injections because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.
Product
Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Distribution
0 states
ModerateFDA (Drugs)··2014-08-13
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.
Product
Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Distribution
0 states
ModerateFDA (Drugs)··2014-08-13
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin Injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA or ANDA.
Product
Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Distribution
0 states
SevereFDA (Drugs)··2014-08-13
B Complex Injection Recalled for Lack of FDA Approval
Medical Supply Liquidators LLC is recalling B Complex for Injection USP with Methylcobalamin because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.
Product
B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-08-13
FDA Recalls G.A.C. 375 Injection Due to Unregistered Manufacturer
The FDA is recalling G.A.C. 375 Injection USP because the manufacturing firm is not registered with the FDA as a drug manufacturer.
Product
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.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-08-13
FDA Recalls Unapproved Vitamin B12 Injection Vials
Medical Supply Liquidators LLC is recalling Vitamin B12 Hydroxocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.
Product
Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Distribution
0 states
ModerateFDA (Drugs)··2014-08-13
FDA Recalls Unapproved Glutathione Injection Vials Nationwide and Abroad
Medical Supply Liquidators LLC is recalling Glutathione Injection USP vials because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.
Product
Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-08-13
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin 5000 Injection USP because the manufacturer is not registered with the FDA.
Product
Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-08-13
L-Carnitine Injection Recalled for Lack of FDA Approval and Registration
Medical Supply Liquidators LLC is recalling L-Carnitine Injection USP 100 mg/ml because it was marketed without an approved NDA/ANDA and the manufacturer is not registered with the FDA.
Product
L-Carnitine Injection USP 100 mg/ml, 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.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-08-13
Unapproved Injectable B Complex Recall Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Super MIC B Complex injections because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.
Product
Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Distribution
0 states
ModerateFDA (Drugs)··2014-08-13
Medical Supply Liquidators Recalls Unapproved MIC Injection Vials
Medical Supply Liquidators LLC is recalling MIC Injection USP vials because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.
Product
MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Distribution
0 states
SevereFDA (Drugs)··2014-08-13
FDA Recalls Unapproved Lipo 8 Injection Vials Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Lipo 8 Injection USP 200 mg/ml vials because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.
Product
Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Distribution
0 states