Multi-event November 2021 FDA Recall Drug by Asp Cares

This Multi-event Class II drug recall was voluntarily initiated by Asp Cares on November 17, 2021 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in United States and the recall is currently terminated.

Reported Recall Events

D-0260-2022 TERMINATED D-0262-2022 TERMINATED D-0261-2022 TERMINATED

Recall Number: D-0260-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-17-2021
Reported
12-08-2021
Quantity
1605 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ASP CARES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2022
Product Description About Product Description
Full technical description of the product.
Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30

Batch or Lot Expiration Information

Lot# Lot: 082921565 BUD: 02/25/2022

Recall Number: D-0262-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-17-2021
Reported
12-08-2021
Quantity
3077 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ASP CARES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2022
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50

Batch or Lot Expiration Information

Lot# Lots: 092321690 BUD: 03/22/2022; 093021690 BUD: 03/29/2022

Recall Number: D-0261-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
11-17-2021
Reported
12-08-2021
Quantity
896 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ASP CARES
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2022
Product Description About Product Description
Full technical description of the product.
Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30

Batch or Lot Expiration Information

Lot# Lot: 091721589 BUD: 03/16/2022