Morphine Sulfate Syringe Recall Due to Labeling Mix-Up
STAQ Pharma is recalling a limited number of syringes labeled as Morphine Sulfate PF that actually contain HYDROmorphone HCl PF due to a labeling error. The affected lot was distributed to Colorado, Ohio, and Texas.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. According to the severity rubric, FDA Class I recalls are never scored below 4. The labeling error involves two distinct opioid medications, creating significant risk of patient harm through medication administration error.
Plain-English summary
STAQ Pharma, Inc. is recalling Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL single-dose syringes (NDC: 73177-0105-04, Lot Number 21104221A, Expiration date 05-22-2022) because a limited number of syringes were incorrectly labeled.
The syringes containing HYDROmorphone HCl PF were mislabeled as Morphine Sulfate PF. This labeling error creates a risk of administering the wrong medication to patients.
The affected syringes were distributed to Colorado, Ohio, and Texas. Healthcare providers and patients who received syringes from this lot should immediately verify the actual contents of the syringes against the label and contact their pharmacy or healthcare provider if they have questions about whether their product is affected.
The recalled product
- Product
- Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0105-04.
- Manufacturer
- STAQ Pharma, Inc.
- Category
- Drug — Injectable / Opioid
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 Number: 21104221A
- Expiration date: 05-22-2022
Distribution
Part of a larger recall action
This product is one of 2 recalled by STAQ Pharma, Inc. 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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