Why it was recalled
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Product description
Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (NDC 38779-0989-09), and 25 kg drum (NDC 38779-0989-07), Rx only, Packed by Medisca Inc., Plattsburgh, NY 12901, CAS: 60-32-1. 38779-0989-05; jar, 300 ml, white HDPE 38779-0989-07; drum, 15 gallon, Fiber 38779-0989-09; 2.8L, white, HDPE
Lot numbers, UPCs & expiration codes
Lots# 143595/A,143595/B,143595/D, Exp 02/28/20
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1174-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 14, 2017
- FDA report date
- Sep 27, 2017
- Quantity
- 34,600 g
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medisca, Inc.
Original FDA data
Every field from FDA enforcement report D-1174-2017, exactly as published.
Show all FDA fields
- City
- Plattsburgh
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 78123
- Address
- 661 State Route 3 Unit C
- Code information
- Lots# 143595/A,143595/B,143595/D, Exp 02/28/20
- Postal code
- 12901-6531
- Report date
- Sep 27, 2017
- Product type
- Drugs
- Recall number
- D-1174-2017
- Classification
- Class II
- Recalling firm
- Medisca, Inc.
- Product quantity
- 34,600 g
- Termination date
- Dec 4, 2018
- Reason for recall
- CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (NDC 38779-0989-09), and 25 kg drum (NDC 38779-0989-07), Rx only, Packed by Medisca Inc., Plattsburgh, NY 12901, CAS: 60-32-1. 38779-0989-05; jar, 300 ml, white HDPE 38779-0989-07; drum, 15 gallon, Fiber 38779-0989-09; 2.8L, white, HDPE
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 20, 2017