Oxycodone HCl Oral Concentrate Recalled Due to Incorrect Morphine Labeling
Shamrock Medical Solutions is recalling Oxycodone HCl Oral Concentrate that was incorrectly labeled as Morphine Sulfate. The product was distributed to Colorado, Massachusetts, Ohio, Texas, and Wyoming.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which is defined as a situation where use or exposure to a product may cause serious adverse health consequences or death. Mislabeling one opioid as another is a critical hazard.
Plain-English summary
Shamrock Medical Solutions Group LLC is recalling Oxycodone HCl Oral Concentrate, 20 mg/mL, which was packaged and labeled as Morphine Sulfate 20 mg/mL. The product was originally manufactured by Lannett Co. Inc. and re-packaged by Shamrock Medical Solutions in Lewis Center, Ohio. The specific lot number is 002HZI, with a use-by date of 7/20/2013 and NDC 00527-1426-36.
The recall was initiated due to a labeling error where the product was misidentified. Although the label indicated Morphine Sulfate, the actual contents were Oxycodone HCl. Both are potent opioid analgesics, and the mislabeling poses a significant risk of medication errors.
The affected product was shipped to the states of Colorado, Massachusetts, Ohio, Texas, and Wyoming. Consumers and healthcare providers should check their inventory for this specific NDC and lot number. If found, the product should be returned to the pharmacy or supplier for disposal or credit.
The recalled product
- Product
- Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36
- Manufacturer
- Shamrock Medical Solutions Group LLC
- Category
- Drug — Opioid Analgesic
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 (1)
- Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36
Distribution
Part of a larger recall action
This product is one of 6 recalled by Shamrock Medical Solutions Group LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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