The Recall Desk
SevereFDA (Drugs)·D-1521-2014·Announced 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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the lack of regulatory approval for an injectable drug.

Plain-English summary

Medical Supply Liquidators LLC is recalling BCAA 4% Branched Chain Amino Acid Injection USP, sterile, 30 ml vials. The product is intended for intramuscular (IM) or deep subcutaneous (SQ) use and is a multiple-dose vial. It was manufactured by CB Inc. for Sunshine Labs.

The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the manufacturing firm is not registered with the FDA as a drug manufacturer. The recall covers all lot numbers and expiration dates.

Distribution was made nationwide and to foreign countries including Canada, the United Kingdom, Australia, Slovenia, Germany, Spain, Finland, and Croatia. Consumers and healthcare providers should stop using the product and contact the recalling firm for further instructions.

The recalled product

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
Manufacturer
Medical Supply Liquidators Llc
Category
Drug — Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lot numbers and exp dates

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Medical Supply Liquidators Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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