Why it was recalled
Failed Stability Specification; product viscosity and or pH are below specification.
Product description
Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.
Lot numbers, UPCs & expiration codes
Batch no: 1) 614463 (exp. 03/2014), 2) 612905 (exp. 12/2013), 3) 614923 (exp. 03/2014), 4) 615852 (exp. 05/2014), 5) 615855 (exp. 05/2014), 6) 616689 (exp. 07/2014), 7) 616692 (exp. 07/2014).
Where it was sold
Nationwide
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-389-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 28, 2013
- FDA report date
- Jan 1, 2014
- Quantity
- 51.948 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
Original FDA data
Every field from FDA enforcement report D-389-2014, exactly as published.
Show all FDA fields
- City
- Amityville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 66675
- Address
- 369 Bayview Ave
- Code information
- Batch no: 1) 614463 (exp. 03/2014), 2) 612905 (exp. 12/2013), 3) 614923 (exp. 03/2014), 4) 615852 (exp. 05/2014), 5) 615855 (exp. 05/2014), 6) 616689 (exp. 07/2014), 7) 616692 (exp. 07/2014).
- Postal code
- 11701-2801
- Report date
- Jan 1, 2014
- Product type
- Drugs
- Recall number
- D-389-2014
- Classification
- Class III
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Product quantity
- 51.948 bottles
- Termination date
- May 16, 2016
- Reason for recall
- Failed Stability Specification; product viscosity and or pH are below specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 28, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 24, 2013