Food, drugs, devices › The Harvard Drug Group
Drug recall: Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Privat
FDA enforcement event 78162 is a drug recall by The Harvard Drug Group of Livonia, MI, initiated 26 Sep 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 29 Apr 2020. Initiation: voluntary: firm initiated. The Harvard Drug Group has 21 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
The Harvard Drug Group, Livonia, MI.
Reason for recall
"Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity."
Distribution
"Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0013-2018 | Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI… | 3,935 cartons | Class II | Terminated | 25 Oct 2017 |
Context
Other enforcement events for The Harvard Drug Group
All 21 events for The Harvard Drug Group
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Apr 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.