Tris Pharma Recalls Morphine Sulfate Oral Solution Due to Leaking
Tris Pharma is recalling 34,824 bottles of Morphine Sulfate Oral Solution because the liquid is leaking from the containers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a packaging issue (leaking) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Tris Pharma Inc. is recalling 34,824 bottles of Morphine Sulfate Oral Solution, 100 mg/5 mL (20 mg/mL). The product is packaged in 1 oz. bottles containing 30 mL with an oral syringe and is available by prescription only.
The recall was initiated because the oral solution is leaking from the container. The affected product is identified by NDC 27808-082-01 and includes lot numbers 08215001A (expiration 6/30/2017), 08215002A, and 08215004A (expiration 7/31/2017). The product was distributed nationwide in the U.S.A.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- MORPHINE SULFATE (MORPHINE SULFATE)
- Brand
- MORPHINE SULFATE
- Manufacturer
- Tris Pharma Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 34,824
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 (5)
- Lot #: 08215001A
- Exp 6/30/2017
- 08215002A
- 08215004A
- Exp 7/31/2017
UPCs (2)
- 0327808082015
- 0327808082022
Distribution
Distributed nationwide across the United States.
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