Recalls / Class II
Class IID-0664-2017
Product
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
- Affected lot / code info
- a) 124880/D,124880/O, 130940/J, 135312/E b) 124880/C 124880/F 124880/I 124880/N 130940/D 130940/I 135312/D 135312/I 136546/D 139489/B c) 124880/B, 124880/H, 124880/M, 130940/C, 130940/H, 135312/C, 135312/H, 136546/C d) 124880/A ,130940/B, 130940/G, 135312/B, 135312/G, 136546/B, 139489/A e) 124880/G, 124880/J, 124880/L,130940/A, 130940/F, 135312/A, 135312/F, 136546/A
Why it was recalled
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Recalling firm
- Firm
- Medisca, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 661 State Route 3 Unit C, N/A, Plattsburgh, New York 12901-6531
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
Timeline
- Recall initiated
- 2017-04-03
- FDA classified
- 2017-04-12
- Posted by FDA
- 2017-04-19
- Terminated
- 2019-06-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0664-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.