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Recall Observatory FDA recall evidence

Drug product

Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

D-1179-2019

April 02, 2019

Class II

Product summary

Firm
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Event
Event 82554
Status
Terminated
Classification
Class II
Quantity
10 syringes
Official record key
drug-enforcement:D-1179-2019

Official wording

Reason: Lack of sterility assurance.

Code information: All Lots

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility