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
Summary
The FDA issued a Class I for Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syr by STAQ Pharma, Inc.. Reason: Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 2.
Details
Source
Drug Recall
External ID
D-0634-2022
Action Date
2022-02-23
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot Number: 21104221A, Expiration date: 05-22-2022
Quantity Affected: n/a
Reason for Recall
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Distribution
CO, OH, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-03
Company
Denver, CO
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
STAQ Pharma, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (STAQ Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does STAQ Pharma, Inc. have FDA actions?
STAQ Pharma, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0634-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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