Multi-event February 2022 FDA Recall Drug by Staq Pharma, Inc.

This Multi-event Class I drug recall was voluntarily initiated by Staq Pharma, Inc. on February 3, 2022 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in CO, OH, and TX. and the recall is currently terminated.

Reported Recall Events

D-0633-2022 TERMINATED D-0634-2022 TERMINATED

Recall Number: D-0633-2022

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
Initiated
02-03-2022
Reported
02-23-2022
Quantity
905 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89550
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
STAQ Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, OH, and TX.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2022
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05.

Batch or Lot Expiration Information

Lot# Lot Number: 21104221A, Expiration date: 05-22-2022

Recall Number: D-0634-2022

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
Initiated
02-03-2022
Reported
02-23-2022
Quantity
n/a

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89550
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
STAQ Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO, OH, and TX.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2022
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot Number: 21104221A, Expiration date: 05-22-2022