Drug Enforcement D-0373-2024

cGMP Deviations: Products were stored outside the drug label specifications.

Status

Terminated

Classification

Class II

Report Date

March 20, 2024

Termination Date

August 14, 2024

Product Information

Product description
Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
Product quantity
70 vials
Reason for recall
cGMP Deviations: Products were stored outside the drug label specifications.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Product was distributed to three direct accounts in NM, AZ and UT.

Location & Firm

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Address
9954 Maryland Drive, Deep Run Iii Ste. 4000

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0373-2024
Event ID
93935
Recall initiation date
February 7, 2024
Center classification date
March 8, 2024
Code info
567951
More code info