Columbus, OH, United States
Slate Run Pharmaceuticals recalls
2 recalls recorded since 2018, most recently on 12 February 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 12 February 2026
- Reason
- Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
- Distribution
- Nationwide within the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0343-2026
- Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Are
Completed Class II Drugs
- Recall started
- 7 March 2025
- Reason
- CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
- Distribution
- Product was distributed to 8 distributors who may have further distribute the product nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0279-2025, D-0278-2025
- Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
- Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.