FDA Recalls NDC 0703-0051 Methylprednisolone Acetate
Injection, Suspension Intra-articular; Intralesional; Intramuscular; Soft Tissue

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Methylprednisolone Acetate with NDC 0703-0051 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-1070-2022 and the recall is currently ongoing .

Recall Number	Initiation Date	Report Date	Recall Classification	Product Quantity	Product Description	Status
D-1070-2022	04-13-2022	06-15-2022	Class II	983 cartons/1 vial each and 107 cartons/25 vials each	MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0031-01), b) 25-count box (NDC 0703-0031-04), Rx only, MFG: Teva Pharma USA	Ongoing
D-1073-2022	04-13-2022	06-15-2022	Class II	1088 cartons/1 vial each and 63 cartons/25 vials each	MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0051-01) b) 25-count box (NDC 0703-0051-04), Rx only, MFG: Teva Pharma USA	Ongoing
D-0743-2021	07-29-2021	08-25-2021	Class II	50,713 vials	Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.	Ongoing
D-0731-2021	07-29-2021	08-25-2021	Class II	193,845 vials	Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.	Ongoing
D-0281-2021	02-10-2021	03-03-2021	Class II	5,378 vials	MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.	Ongoing
D-0275-2021	02-10-2021	03-03-2021	Class II	5,086 vials	MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.	Ongoing

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.

Field Name	Field Value
Event ID	89646 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1070-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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".
Distribution Pattern	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.
Product Description	MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0031-01), b) 25-count box (NDC 0703-0031-04), Rx only, MFG: Teva Pharma USA
Reason For Recall	cGMP deviations: Temperature abuse What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	983 cartons/1 vial each and 107 cartons/25 vials each Product Quantity The amount of product subject to recall.
Voluntary Mandated	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.
Report Date	06-15-2022
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.
Product Type	Drugs
Recalling Firm	Mckesson Medical-Surgical Inc. Corporate Office
Code Info	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	0703-0031-01; 0703-0031-04; 0703-0051-01; 0703-0051-04
Status	Ongoing

Field Name	Field Value
Event ID	89646 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1073-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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".
Distribution Pattern	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.
Product Description	MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0051-01) b) 25-count box (NDC 0703-0051-04), Rx only, MFG: Teva Pharma USA
Reason For Recall	cGMP deviations: Temperature abuse What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1088 cartons/1 vial each and 63 cartons/25 vials each Product Quantity The amount of product subject to recall.
Voluntary Mandated	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.
Report Date	06-15-2022
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.
Product Type	Drugs
Recalling Firm	Mckesson Medical-Surgical Inc. Corporate Office
Code Info	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	0703-0031-01; 0703-0031-04; 0703-0051-01; 0703-0051-04
Status	Ongoing

Field Name	Field Value
Event ID	88442 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0743-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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".
Distribution Pattern	Product was distributed Nationwide, including Puerto Rico. 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.
Product Description	Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	50,713 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	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.
Report Date	08-25-2021
Recall Initiation Date	07-29-2021 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.
Product Type	Drugs
Recalling Firm	Teva Pharmaceuticals USA
Code Info	Lot #: a) 31329363B, exp. date 01/2022; 31329484B, exp. date 03/2022 b) 31328367B, 31328431B, exp. date 07/2021; 31329014B, exp. date 11/2021 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	0703-0031-01; 0703-0031-04; 0703-0051-01; 0703-0051-04; 0703-0043-01; 0703-0045-01; 0703-0063-01
Status	Ongoing

Field Name	Field Value
Event ID	88442 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0731-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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".
Distribution Pattern	Product was distributed Nationwide, including Puerto Rico. 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.
Product Description	Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	193,845 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	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.
Report Date	08-25-2021
Recall Initiation Date	07-29-2021 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.
Product Type	Drugs
Recalling Firm	Teva Pharmaceuticals USA
Code Info	Lot #: a) 31328455B, exp. date 09/2021; 31329340B, exp. date 12/2021; 31329439B, exp. date 01/2022; 31328347B, exp. date 07/2021 b) 31328321B, exp. date 07/2021; c) 31328368B, 31328394B, exp. date 07/2021; 31328699B, exp. date 09/2021; 31328834B, exp. date 10/2021; 31329286B, exp. date 12/2021 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	0703-0031-01; 0703-0031-04; 0703-0051-01; 0703-0051-04; 0703-0043-01; 0703-0045-01; 0703-0063-01
Status	Ongoing

Field Name	Field Value
Event ID	87298 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0281-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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".
Distribution Pattern	Product was distributed nationwide in the USA and Puerto Rico. 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.
Product Description	MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Reason For Recall	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	5,378 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	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.
Report Date	03-03-2021
Recall Initiation Date	02-10-2021 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.
Product Type	Drugs
Recalling Firm	Teva Pharmaceuticals USA
Code Info	Lot # 31327909B, exp. date 04/2021 Lot # 31328352B, exp. date 07/2021 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	0703-0031-01; 0703-0031-04; 0703-0051-01; 0703-0051-04
Status	Ongoing

Field Name	Field Value
Event ID	87298 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0275-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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".
Distribution Pattern	Product was distributed nationwide in the USA and Puerto Rico. 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.
Product Description	MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Reason For Recall	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	5,086 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	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.
Report Date	03-03-2021
Recall Initiation Date	02-10-2021 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.
Product Type	Drugs
Recalling Firm	Teva Pharmaceuticals USA
Code Info	Lot # 31327742B, exp. date 02/2021 Lot # 31328408B, exp. date 07/2021 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	0703-0031-01; 0703-0031-04; 0703-0051-01; 0703-0051-04
Status	Ongoing