Why it was recalled
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Product description
AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32
Lot numbers, UPCs & expiration codes
Lot: VEAC025, EXP 10-2019
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-1398-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 21, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 14,960 4 mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Heritage Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1398-2019, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82918
- Address
- 1 Tower Center Blvd Ste 1700
- Code information
- Lot: VEAC025, EXP 10-2019
- Postal code
- 08816-1145
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1398-2019
- Classification
- Class I
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- Product quantity
- 14,960 4 mL vials
- Termination date
- Jan 11, 2022
- Reason for recall
- Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 21, 2019
- Initial firm notification
- Press Release
- Center classification date
- Jun 19, 2019