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U.S. Department of Health and Human Services

Drugs

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Questions and Answers for Consumers about FDA’s Action Involving Unapproved Codeine Sulfate Tablets

What action is FDA taking regarding codeine sulfate tablets?

The Food and Drug Administration (FDA) has sent Warning Letters directing companies to stop making and distributing 30 mg and 60 mg codeine sulfate tablets that lack the required FDA approval.  Table 1 provides a list of the specific unapproved drug products involved in this action.

When is this action going to take effect?

Manufacturers have 90 days after the date of their Warning Letter to stop manufacturing new products, and distributors have 180 days after the date of their Warning Letter to stop further shipment of existing products. 

Are these products recalled from the pharmacy?

No, this is not a recall.  Previously manufactured unapproved products affected by this action may still be found on pharmacy shelves for a short period of time until the inventory has been depleted or the product has become expired, whichever occurs first.

Why is FDA taking this action?

FDA is taking this action as part of its continuing effort to ensure that drugs marketed in the U.S. have the required FDA approval, which means that they have been found to be safe, effective, of good quality, and appropriately labeled. 

What effect will FDA’s action have on people who use codeine sulfate tablets? Are there alternatives?

Consumers will continue to have access to FDA-approved codeine sulfate tablets.  One firm markets FDA-approved codeine sulfate products available in 30 mg and 60 mg strength tablets.  See Table 2.  There are also other FDA-approved drugs, including different narcotics, which can be used to relieve pain.  Consumers should consult a healthcare professional for detailed guidance on their treatment options. 

What is Codeine Sulfate?

Codeine Sulfate is an opioid analgesic (sometimes called a narcotic) used to relieve mild to moderately severe pain where the use of an opioid analgesic is appropriate. 

How can people tell the difference between FDA-approved and unapproved products?

While the FDA works to ensure that all marketed unapproved drug products obtain approval or are removed from the market FDA provides various resources that list approved drugs. Healthcare practitioners and consumers can use Drugs@FDA, National Drug Code (NDC) Directory, or Orange Book to determine whether a drug is FDA-approved.  Drugs@FDA contains most FDA-approved drug products.  The NDC Directory is limited to prescription drugs and insulin products.  Search results from the NDC directory include a column marked "Application Number."  FDA-approved products will have an associated NDA (new drug application) or ANDA (abbreviated new drug application) number in this column. Identification of a drug product as "other" indicates that the product has not been FDA-approved (unless there is a data error or the firm did not provide the product's application number).  In the Orange Book, if the product is FDA approved, then the search results will list approved products (note the application number in the "Appl No" column) by dosage form, route, and name of applicant.  If the product is not in the FDA approved list, then the results will state, "No matching records found."

Is it safe to use the unapproved products?

The safety of unapproved drugs is unknown.  Approved codeine sulfate tablets have labeling that has been specifically reviewed and approved by FDA, and that reflects the risks, benefits, and safe use of these drugs. This information may not be contained in the labeling of the unapproved products. 

The drug approval process enables FDA to evaluate the drug’s formulation, manufacturing process, and labeling, as well as any changes that occur after approval. 

Should I keep taking my medications?

Consumers who have concerns about their medications should speak to their healthcare professionals about replacement prescriptions. The lists of approved and unapproved codeine sulfate tablets are below. 

Table 1.  List of Unapproved Codeine Sulfate Tablets Subject to Warning Letters

Drug Product Firm NDC #

Codeine Sulfate Tablets

30 mg

60 mg

Cerovene Inc.

 

24561-*001-10

24561-*002-10

 

Codeine Sulfate Tablets

30 mg

Dava International Inc.

 

 

67253-*350-10

Codeine Sulfate Tablets

30 mg

60 mg

Glenmark Generics Inc.

 

 

68462-*193-01

68462-*194-01

Codeine Sulfate Tablets

30 mg

60 mg

Lehigh Valley Technologies Inc.

 

 

64950-*193-01

64950-*194-01

Table 2.  List of FDA-Approved Codeine Sulfate Tablets

Drug Product Firm NDC # NDA#

Codeine Sulfate Tablets 15 mg

30 mg

 

60 mg

 

Roxane Laboratories Inc.

Roxane Laboratories Inc.

Roxane Laboratories Inc.

Roxane Laboratories Inc.

 

00054-8155-24

00054-8156-24

00054-4156-25

00054-4157-25

 

022402

022402

022402

022402