Upsher Smith Recalls Oxandrolone Tablets Due to Missing Primary Labels
Upsher Smith Laboratories is recalling 36 bottles of Oxandrolone Tablets, USP, 10 mg, because they were packaged without primary labels.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is limited to missing primary labels on a small number of bottles.
Plain-English summary
Upsher Smith Laboratories, Inc. is recalling 36 bottles of Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottles (NDC 0245-0272-06). The recall involves Lot #2802.042A, which has an expiration date of 10/2015. The affected product was manufactured by Pharmaceutics International, Inc., for Upsher-Smith Labs.
The recall was initiated because three cases of the product, totaling 36 bottles, were packaged without the primary label on the bottle. Although the bottles lacked primary labels, they were packaged in the correct finished product shipper, labeled with the correct shipper bar code label, and sealed with tamper-evident tape. These cases were erroneously shipped to Upsher-Smith.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers with this specific lot of Oxandrolone Tablets should contact their pharmacist or Upsher Smith Laboratories for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Upsher Smith Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,185
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #2802.042A
- Exp. 10/2015
Distribution
Distributed nationwide across the United States.
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