← FDA ENFORCEMENT
D-1144-2023Class III

Caplin Steriles Limited

Recalling firm
Caplin Steriles Limited
Product type
Drug
Status
Terminated
Report date
2023-09-13
Distribution
Nationwide in Tennessee
Firm state
N/A
Product quantity
19, 820 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Impurities/Degradation Specifications

Product description

Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10

Code / lot info

Lot #: 90000228

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.