Exact FDA event identifier

Event 73537

7 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 14, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Meditech Laboratories, Inc

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 7

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

D-0802-2016

Recall number: D-0802-2016
Initiated: March 14, 2016
Classification: Class II
Status: Terminated
Recalling firm: Meditech Laboratories, Inc
Quantity: 1320 vials - all formulas

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: one ingredient was found to be above assay specification.

Code information

Lot #: 110115-2, Exp 01/01/16

Distribution pattern

Nationwide

drug · product 2 of 7

Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .

D-0803-2016

Recall number: D-0803-2016
Initiated: March 14, 2016
Classification: Class II
Status: Terminated
Recalling firm: Meditech Laboratories, Inc
Quantity: 1320 vials - all formulas

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: incomplete or missing data regarding production.

Code information

Lot#: 022316-4, Exp 04/08/16

Distribution pattern

Nationwide

drug · product 3 of 7

Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

D-0804-2016

Recall number: D-0804-2016
Initiated: March 14, 2016
Classification: Class II
Status: Terminated
Recalling firm: Meditech Laboratories, Inc
Quantity: 1320 vials - all formulas

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: incomplete or missing data regarding production.

Code information

Lot#: 022416-9, Exp 04/09/16.

Distribution pattern

Nationwide

drug · product 4 of 7

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.

D-0805-2016

Recall number: D-0805-2016
Initiated: March 14, 2016
Classification: Class II
Status: Terminated
Recalling firm: Meditech Laboratories, Inc
Quantity: 1320 vials - all formulas

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Code information

Lot#: 011916-1, Exp 04/19/16; 020316-1, Exp 05/03/16

Distribution pattern

Nationwide

drug · product 5 of 7

Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

D-0806-2016

Recall number: D-0806-2016
Initiated: March 14, 2016
Classification: Class II
Status: Terminated
Recalling firm: Meditech Laboratories, Inc
Quantity: 1320 vials - all formulas

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Code information

Lot#: 011716-3, Exp 04/17/16; 012416-3, Exp 04/24/16.

Distribution pattern

Nationwide

drug · product 6 of 7

Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

D-0807-2016

Recall number: D-0807-2016
Initiated: March 14, 2016
Classification: Class II
Status: Terminated
Recalling firm: Meditech Laboratories, Inc
Quantity: 1320 vials - all formulas

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: incomplete or missing data regarding production.

Code information

Lot#: 020716-0, Exp 05/07/16

Distribution pattern

Nationwide

drug · product 7 of 7

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

D-0808-2016

Recall number: D-0808-2016
Initiated: March 14, 2016
Classification: Class II
Status: Terminated
Recalling firm: Meditech Laboratories, Inc
Quantity: 1320 vials - all formulas

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Code information

Lot #: 12216-2, Exp 04/22/16

Distribution pattern

Nationwide