Agency classClass IIOur severity:Severe FDA (Drugs)·D-1531-2014·Announced 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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling G.A.C. 375 Injection USP, packaged in 30 ml vials. The product is sterile and intended for intramuscular (IM) or deep subcutaneous (SQ) use. It is a multiple-dose vial manufactured by CB Inc. for Sunshine Labs.

The recall was initiated 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 is classified as Class II by the FDA. The product was distributed nationwide and to Canada, the United Kingdom, Australia, Slovenia, Germany, Spain, Finland, and Croatia. All lot numbers and expiration dates are affected. Consumers and healthcare providers should stop using the product and contact the recalling firm, Medical Supply Liquidators Llc, for further instructions.

The recalled product

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.
Manufacturer: Medical Supply Liquidators Llc
Category: Drug — Injectable
Hazard: unapproved-drug
unregistered-manufacturer

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 →

Same manufacturer · Medical Supply Liquidators Llc

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