FindMyRecallSubscribe
Class III: unlikely to cause harmTerminated

Silarx Pharmaceutical Lamivudine Oral Solution Recall

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manuf…

Silarx Pharmaceutical, Inc. · Carmel, NY

Risk level
Class III
Reported by FDA
Sep 9, 2015
Recall ID
D-1416-2015
Check your lot numberHow we source this data

Summary

Silarx Pharmaceutical recalled Lamivudine Oral Solution starting Aug 21, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1416-2015 on Sep 9, 2015. Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17). Status: Terminated.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).

Product description

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70

Lot numbers, UPCs & expiration codes

Lot # 0649A Exp. Date 05/18 (unit carton)

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1416-2015
Classification
Class III
Status
Terminated
Recall initiated
Aug 21, 2015
FDA report date
Sep 9, 2015
Quantity
576 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Silarx Pharmaceutical, Inc.

Original FDA data

Every field from FDA enforcement report D-1416-2015, exactly as published.

Show all FDA fields
City
Carmel
State
NY
Status
Terminated
Country
United States
Event ID
71952
Address
1033 Stoneleigh Ave
Code information
Lot # 0649A Exp. Date 05/18 (unit carton)
Postal code
10512-2414
Report date
Sep 9, 2015
Product type
Drugs
Recall number
D-1416-2015
Classification
Class III
Recalling firm
Silarx Pharmaceutical, Inc.
Product quantity
576 bottles
Termination date
Dec 2, 2015
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70
Distribution pattern
Nationwide
Recall initiation date
Aug 21, 2015
Initial firm notification
Letter
Center classification date
Sep 3, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1416-2015, published Sep 9, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls