Multi-event March 2025 FDA Recall Drug by Slate Run Pharmaceuticals
This Multi-event Class II drug recall was voluntarily initiated by Slate Run Pharmaceuticals on March 7, 2025 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently completed.
Reported Recall Events
Recall Number: D-0279-2025
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
03-07-2025
03-26-2025
2,444 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Slate Run Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 109797, Exp 11/2026
Recall Number: D-0278-2025
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
03-07-2025
03-26-2025
56,790 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Slate Run Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
