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High RiskFDAfda-D-825-2013CONTAMINATION

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pha...

Category
Units Affected
7,324
Recall Date
May 16, 2013
Issuing Agency
Hazard
Contamination

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-825-2013.

Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-825-2013.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-825-2013.

West-Ward Pharmaceutical Corp.

FDA

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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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West-ward Pharmaceutical Corp. Recall FAQ

West-ward Pharmaceutical Corp. is the subject of an oral drugs safety report: West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pha.... The notice was published on May 16, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 7,324 units are potentially affected.