drugs MODERATE Updated 2016-10-19

Hospira Inc., A Pfizer Company recalls Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 m

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Recalled Product

Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.

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Hazard / Issue

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 60295DD, Ep 1DEC2017

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall