The last Recall Enforcement Report for Methylprednisolone Acetate with NDC 16714-088 was initiated on 04-13-2022 as a Class II recall due to cgmp deviations: temperature abuse The latest recall number for this product is D-1061-2022 and the recall is currently ongoing .
Recall Number D-1061-2022
||89646 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
||D-1061-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
||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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
||USA nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
||MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) single dose vial (NDC 6714-088-01) b) 25-count box (NDC16714-088-25), Rx only, MFG: NorthstarRx/Teva Pharma USA
|Reason For Recall
||cGMP deviations: Temperature abuse What is the Reason for Recall?
Information describing how the product is defective.
||885 vials Product Quantity
The amount of product subject to recall.
||Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
|Recall Initiation Date
||04-13-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
|Initial Firm Notification
||Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
||Mckesson Medical-Surgical Inc. Corporate Office
||McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
|Recalled NDC Packages
||16714-088-01; 16714-088-25; 16714-472-01; 16714-472-25
||View Recall Report
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.