RecallRadar

FDA Drug recall D-1097-2022

Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 2…

On 2022-06-15 the FDA classified a Class II recall of Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 2… by Mckesson Medical Surgical Corporate Office, citing cGMP deviations: Temperature abuse.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1097-2022
ClassificationClass II
Statusterminated
Initiated2022-04-13
Published2022-06-15
Last updated2026-09-13 11:52 UTC
CompanyMckesson Medical Surgical Corporate Office
DistributionUS

Product

Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 25-count box (NDC 0009-3475-03), Rx only, MFG: Pfizer

Reason

cGMP deviations: Temperature abuse

Identifiers

ndc0009-3073-01
ndc0009-3073-03
ndc0009-3475-01
ndc0009-3475-03
code_info
McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee fo…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1097-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.