Safecor Health

50 FDA enforcement records linked to this company.

• 4832026-06-12

  Investigations of discrepancies, failures

• 4832026-06-12

  Prepared for each batch, include complete information

• recall — Class II2026-05-27

  Presence of a Foreign Substance; black particles observed in liquid

• recall — Class II2026-05-27

  Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

• recall — Class II2025-12-10

  Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

• 4832025-10-28

  Procedures not in writing, fully followed

• recall — Class II2025-03-12

  Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

• recall — Class II2025-03-12

  Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

• recall — Class II2025-03-12

  Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

• recall — Class II2025-03-12

  Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

• recall — Class II2025-03-12

  Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

• recall — Class II2024-11-27

  cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

• recall — Class II2024-11-27

  cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

• recall — Class II2024-11-27

  cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

• recall — Class II2024-11-27

  cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.