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
Reported: April 30, 2014 Initiated: April 14, 2014 #D-1255-2014
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
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.
Details
- Recalling Firm
- Upsher Smith Laboratories, Inc.
- Units Affected
- 1,185 bottles
- Distribution
- Nationwide
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Upsher Smith Laboratories, Inc.. Units affected: 1,185 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 30, 2014. Severity: Low. Recall number: D-1255-2014.
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