Why it was recalled
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
Product description
Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06
Lot numbers, UPCs & expiration codes
Lot #2802.042A, Exp. 10/2015
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-1255-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 14, 2014
- FDA report date
- Apr 30, 2014
- Quantity
- 1,185 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Upsher Smith Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1255-2014, exactly as published.
Show all FDA fields
- City
- Maple Grove
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 68049
- Address
- 6701 Evenstad Drive
- Code information
- Lot #2802.042A, Exp. 10/2015
- Postal code
- 55369
- Report date
- Apr 30, 2014
- Product type
- Drugs
- Recall number
- D-1255-2014
- Classification
- Class III
- Recalling firm
- Upsher Smith Laboratories, Inc.
- Product quantity
- 1,185 bottles
- Termination date
- Jul 1, 2014
- Reason for recall
- Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 14, 2014
- Initial firm notification
- Telephone
- Center classification date
- Apr 23, 2014