D-0805-2016 Class II Terminated
FDA drug recall D-0805-2016 was initiated by Meditech Laboratories, Inc on March 14, 2016 and is designated Class II. Reason for recall: Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date. The recall status is terminated (terminated June 7, 2016). Affected quantity: 1320 vials - all formulas.
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2016
- Initiation Date
- March 14, 2016
- Termination Date
- June 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1320 vials - all formulas
Product Description
Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Reason for Recall
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Distribution Pattern
Nationwide
Code Information
Lot#: 011916-1, Exp 04/19/16; 020316-1, Exp 05/03/16