FDA Recall United States Terminated Historical recordClass III
Hi-Tech Pharmacal Co., Inc.
- Product
- Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 503…
- Published
- December 28, 2016
- Distribution
- CA, FL, ID, IL, LA, MI, NC, NJ, NY, OH,…
Hi-Tech Pharmacal Co., Inc. Recall: Out-of-specification results for pH.
United States
TerminatedClass III
- Company
- Hi-Tech Pharmacal Co., Inc.
- Product
- Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 503…
- Recall date
- July 28, 2014
- Terminated
- September 8, 2017
- Source
- FDA
Reason for recall
Out-of-specification results for pH.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 | Not published in this source record | 22,872 bottles | Lot 618283 (Exp. 01/2015), Lot 620151 (Exp. 03/2015), Lot 623407 (Exp. 09/2015) --- EXTENSION: Lots 620915 (Expiry 04/2015), 622298 (Exp. 07/2015), 624881 (Exp. 12/2015), 625981 (Exp. 02/2016), 626967 (Exp. 04/2016), 627676 (Exp. 05/2016). |
Distribution
- CA
- FL
- ID
- IL
- LA
- MI
- MN
- NC
- ND
- NJ
- NY
- OH
- PA
- SC
- VT and Puerto Rico
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-0817-2017
- Event ID
- 68873
- Status
- Terminated
- Classification
- Class III
- Company
- Hi-Tech Pharmacal Co., Inc.
- Product description
- Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
- Quantity
- 22,872 bottles
- Reason
- Out-of-specification results for pH.
- Recall initiation date
- July 28, 2014
- Report date
- December 28, 2016
- Classification date
- Not published in this source record
- Termination date
- September 8, 2017
- Distribution pattern
- CA, FL, ID, IL, LA, MI, MN, NC, ND, NJ, NY, OH, PA, SC, VT and Puerto Rico
- UPC, lot, and code information
- Lot 618283 (Exp. 01/2015), Lot 620151 (Exp. 03/2015), Lot 623407 (Exp. 09/2015) --- EXTENSION: Lots 620915 (Expiry 04/2015), 622298 (Exp. 07/2015), 624881 (Exp. 12/2015), 625981 (Exp. 02/2016), 626967 (Exp. 04/2016), 627676 (Exp. 05/2016).
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Letter
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: Hi-Tech Pharmacal Co., Inc.
Other recalls from Hi-Tech Pharmacal Co., Inc.
FDA Recall Terminated Historical recordClass II
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.
- Published
- November 5, 2014
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
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.
- Published
- January 1, 2014
- Distribution
- Nationwide
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| California | 1 |
| Florida | 1 |
| Idaho | 1 |
| Illinois | 1 |
| Louisiana | 1 |
| Michigan | 1 |
| Minnesota | 1 |
| North Carolina | 1 |
| North Dakota | 1 |
| New Jersey | 1 |
| New York | 1 |
| Ohio | 1 |
| Pennsylvania | 1 |
| South Carolina | 1 |
| Vermont | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
