Hi Tech Pharmacal recalls
Hi Tech Pharmacal appears in 10 official U.S. recall notices indexed by RecallRadar, most recently on 2016-12-28.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 10 |
|---|---|
| Published | 2013-05-08 to 2016-12-28 |
| By agency | FDA Drug (7), FDA Food (3) |
| By classification | Class III (8), Class II (2) |
| By status | terminated (10) |
| Distribution named in notices | CA, FL, ID, IL, LA, MI, MN, NC, ND, NJ, NY, OH, PA, PR, SC, TX, US, VT |
Recalls
- Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
FDA Food · Class III · 2016-12-28 · Hi Tech Pharmacal
Reason: The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label. - Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
FDA Food · Class III · 2016-12-28 · Hi Tech Pharmacal
Reason: Out-of-specification results for pH. - FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
FDA Food · Class II · 2015-03-11 · Hi Tech Pharmacal
Reason: Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120. - 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 Ph…
FDA Drug · Class II · 2014-11-05 · Hi Tech Pharmacal
Reason: Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station. - Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc
FDA Drug · Class III · 2014-01-01 · Hi Tech Pharmacal
Reason: Failed Stability Specification; product viscosity and or pH are below specification. - GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUS…
FDA Drug · Class III · 2013-10-30 · Hi Tech Pharmacal
Reason: Subpotent; phenylephrine HCl - Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, ND…
FDA Drug · Class III · 2013-08-21 · Hi Tech Pharmacal
Reason: Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP - HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 503…
FDA Drug · Class III · 2013-06-26 · Hi Tech Pharmacal
Reason: Subpotent; 24 month stability test station - BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manu…
FDA Drug · Class III · 2013-05-22 · Hi Tech Pharmacal
Reason: Subpotent; Cetylpyridinum Chloride - Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-8…
FDA Drug · Class III · 2013-05-08 · Hi Tech Pharmacal
Reason: Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.