Reported Dec 6, 2023 · Terminated
Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured…
VistaPharm LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: VistaPharm LLC · 7265 Ulmerton Rd · Largo, FL · 33771-4809
Is this the product you have?
- Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles
- Manufactured forVistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08
- Lot codes and dates
Lot #: 22ZKY1Exp. 11/27/2322ZMC1Exp. 12/21/2322ZTP1Exp. 03/29/2423ZAD1Exp. 07/07/24
- Amount recalled
- Prod Lot number 22ZKY1, EXP 11/27/23, 600 bottles dist; 22ZMC1 EXP12/21/23 600 bottles; 22ZTP1 EXP 03/29/24 588 bottles; 23ZAD1 EXP 07/07/24 564 bottl
Where it was sold
- Nationwide
Why it was recalled
Failed Excipient Specifications: high content of ethylene glycol (EG)
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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