Why it was recalled
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Product description
ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869
Lot numbers, UPCs & expiration codes
a) 137169/F b) 129670/G, 129670/K, 130942/G, 130942/L, 131429/G, 131430/G, 137169/E c) 129670/F,129670/J, 130942/F, 130942/K 131429/F, 131430/F, 137169/D, d) 129670/E, 129670/I,130942/E, 130942/J,131429/E, 131430/E, 137169/C e) 129670/D, 129670/H, 130942/D, 130942/I, 131429/D, 131430/D, 131430/H, 137169/B f) 129670/C, 130942/C, 130942/H, 131429/C, 131430/C, 137169/A, 137169/F g) 129670/B, 130942/B, 131429/B, 131430/B h) 129670/A, 130942/A ,131429/A, 131430/A
Where it was sold
Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
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-0665-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 3, 2017
- FDA report date
- Apr 19, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medisca, Inc.
Original FDA data
Every field from FDA enforcement report D-0665-2017, exactly as published.
Show all FDA fields
- City
- Plattsburgh
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 76873
- Address
- 661 State Route 3 Unit C
- Code information
- a) 137169/F b) 129670/G, 129670/K, 130942/G, 130942/L, 131429/G, 131430/G, 137169/E c) 129670/F,129670/J, 130942/F, 130942/K 131429/F, 131430/F, 137169/D, d) 129670/E, 129670/I,130942/E, 130942/J,131429/E, 131430/E, 137169/C e) 129670/D, 129670/H, 130942/D, 130942/I, 131429/D, 131430/D, 131430/H, 137169/B f) 129670/C, 130942/C, 130942/H, 131429/C, 131430/C, 137169/A, 137169/F g) 129670/B, 130942/B, 131429/B, 131430/B h) 129670/A, 130942/A ,131429/A, 131430/A
- Postal code
- 12901-6531
- Report date
- Apr 19, 2017
- Product type
- Drugs
- Recall number
- D-0665-2017
- Classification
- Class II
- Recalling firm
- Medisca, Inc.
- Termination date
- Jun 18, 2019
- Reason for recall
- cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869
- Distribution pattern
- Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
- Recall initiation date
- Apr 3, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 12, 2017