Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01
Reported: September 6, 2017 Initiated: June 15, 2017 #D-1126-2017
Product Description
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01
Reason for Recall
Defective container: Oral solution leaking from container.
Details
- Recalling Firm
- Tris Pharma Inc.
- Units Affected
- 34,824 bottles
- Distribution
- U.S.A. Nationwide
- Location
- Monmouth Junction, NJ
Frequently Asked Questions
What product was recalled? ▼
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01. Recalled by Tris Pharma Inc.. Units affected: 34,824 bottles.
Why was this product recalled? ▼
Defective container: Oral solution leaking from container.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 6, 2017. Severity: Moderate. Recall number: D-1126-2017.
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